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Germany’s Federal Ministry of Health (BMG) initiated two research funding projects to strengthen women's health | iPharmaCenter
BMG has launched two substantial research funding lines to strengthen women’s health services research in Germany, targeting patient-centered care, junior research groups, and structural capacity building in this field. Germany’s Federal Ministry of Health (BMG) has opened a new women’s health research funding programs to improve healthcare for women across the country. The call targets projects on patient-centered care, sex-specific disease patterns, and the impact of social
J.P. Morgan 2026 Healthcare Conference | News | Updates | iPharmaCenter
Eli Lilly Highlights Expansive Pipeline at JPM 2026, Targeting 1 Billion Patients in High-Volume Diseases Eli Lilly showcased its strategy to address massive patient populations across obesity, diabetes, obstructive sleep apnea, pain, cardiovascular, renal, and hepatic diseases at the 44th Annual J.P. Morgan Healthcare Conference. Also read: Top selling drugs of 2026 Key Pipeline Molecules of Eli Lilly Lilly's key pipeline includes tirzepatide (blockbuster GLP-1/GIP agonist f
Inside Trump’s Great Healthcare Plan: Drug Prices, Premiums, and Transparency Explained
President Donald J. Trump has formally urged Congress to pass the Great Healthcare Plan, a sweeping package designed to cut prescription drug prices, lower health insurance premiums, rein in powerful insurers and pharmacy benefit managers, and expand price transparency across the U.S. healthcare system. iPharmaCenter Consulting: Find services here The White House frames the proposal as a way to send money “directly to the American people” instead of funneling extra taxpayer s
Sun Pharma Launches UNLOXCYT in the U.S. for Advanced Cutaneous Squamous Cell Carcinoma
Sun Pharmaceutical Industries has introduced UNLOXCYT (cosibelimab) in the United States for adult patients diagnosed with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are ineligible for curative surgery or radiation therapy. iPharmaCenter Consulting: Find services here Updated FDA Label Reflects Long-Term Efficacy The U.S. FDA recently approved an updated label for UNLOXCYT following the release of extended follow-up data from
American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium 2026 | News | Updates | iPharmaCenter
Pfizer Braftovi -Based Combination Regimen With Enhanced Chemotherapy Backbone Boosts Response Rates in Select Patients With Metastatic Colorectal Cancer Pfizer has announced new Phase 3 data from the BREAKWATER trial showing that an Braftovi ( encorafenib) based combination can substantially improve response rates in certain patients with advanced colorectal cancer carrying a BRAF V600E mutation. iPharmaCenter Consulting: Find services here In a randomized cohort of previous
Top-Selling Drugs of 2026 | iPharmaCenter
Top-Selling Drugs of 2026: Oncology, Diabetes, and Immunology Take the Lead The pharmaceutical market in 2026 continues to be shaped by powerful forces across oncology, metabolic disorders, and immunology. Driven by expanding therapeutic indications, label extensions, and surging patient demand, the world’s largest drugmakers have seen record-breaking revenues from a handful of blockbuster agents. iPharmaCenter Consulting: Find services here Keytruda: The Unchallenged Leader
Germany Approves Draft Law to Strengthen Local Pharmacies (ApoVWG) | iPharmaCenter
The Federal Cabinet has approved a draft legislation known as the Pharmacy Services Development Act (ApoVWG) on December 17, 2025. This new framework is designed to modernize and enhance the role of pharmacies across Germany, particularly focusing on expanding healthcare access in rural communities and streamlining administrative processes. iPharmaCenter Consulting: Find services here Strengthening Pharmacy Infrastructure The legislation introduces financial support for par
Eli Lilly to acquire Ventyx Biosciences; will significantly strengthen immunology and neurology portfolio | iPharmaCenter
Eli Lilly has entered a definitive agreement to acquire Ventyx Biosciences in an all‑cash transaction valued at approximately 1.2 billion dollars, aiming to strengthen its position in orally delivered therapies for chronic, inflammation‑mediated diseases. Ventyx contributes a differentiated portfolio of small‑molecule oral candidates targeting autoimmune, inflammatory and neurodegenerative diseases, centered on NLRP3 inhibition and advanced IBD assets. iPharmaCenter Consultin
China Grants Approval to Nucala for COPD Management | iPharmaCenter
China’s National Medical Products Administration has officially cleared Nucala (mepolizumab) as a supplemental maintenance therapy for adults suffering from chronic obstructive pulmonary disease (COPD). This authorization specifically targets patients whose condition remains poorly managed and is linked to elevated levels of eosinophils in the blood. Nucala: A Milestone in Biological Respiratory Care Nucala stands as the inaugural monthly biological treatment in China indic
Japan approves GSK's Exdensur for asthma and chronic rhinosinusitis with nasal polyps
Japan has officially sanctioned Exdensur (depemokimab) as a pioneering, ultra-long-lasting biological therapy. This medication is now available for individuals struggling with intense bronchial asthma or chronic rhinosinusitis accompanied by nasal polyps (CRSwNP) who haven't found relief through traditional medical approaches. What distinguishes Exdensur from existing options? Developed by GSK, Exdensur biologic targets type 2 inflammation by binding to interleukin-5 (IL-5) w
Enhertu approved in China for HER2‑low or HER2‑ultralow metastatic breast cancer | iPharmaCenter
Enhertu (trastuzumab deruxtecan) has received marketing authorization in China as the first HER2‑targeting therapy for people with HER2‑low or HER2‑ultralow metastatic breast cancer whose disease has worsened after at least one endocrine treatment in the metastatic setting. The decision is supported by phase 3 DESTINY‑Breast06 data showing clinically meaningful improvements in progression‑free survival versus standard chemotherapy. New indication in China The National Medic
European Commission grants approval to Sanofi's Wayrilz for refractory immune thrombocytopenia | iPharmaCenter
European Commission grants approval to Sanofi's Wayrilz (rilzabrutinib), marking the first Bruton's tyrosine kinase (BTK) inhibitor for adult patients with refractory immune thrombocytopenia (ITP). Wayrilz, an oral and reversible BTK inhibitor, targets immune pathways through multi-immune modulation to tackle ITP's root causes, such as low platelet counts, bleeding risks, and quality-of-life burdens from this rare autoimmune disorder. The approval follows a positive CHMP opin
Boehringer Ingelheim Bolsters Pulmonary Fibrosis Portfolio with Jascayd Approval for Progressive Cases
Boehringer Ingelheim announced US Food and Drug Administration clearance for Jascayd (nerandomilast) tablets to treat progressive pulmonary fibrosis in adults. This marks the second indication for the therapy, following its recent approval for idiopathic pulmonary fibrosis. Jascayd introduces the first selective phosphodiesterase 4B inhibitor with both immune-modulating and anti-scarring properties approved for this serious lung disorder. FIBRONEER-ILD Trial Supports Approv
FDA Clears Wegovy Pill as First Oral GLP-1 for US Weight Management
Novo Nordisk announced US Food and Drug Administration approval for the once-daily Wegovy pill (oral semaglutide 25 mg). This marks the first oral glucagon-like peptide-1 receptor agonist approved specifically for chronic weight control and cardiovascular risk reduction in adults with obesity or overweight plus comorbidities. The therapy targets excess body weight reduction, long-term weight maintenance, and lowering major adverse cardiovascular events in eligible patients.
US FDA Grants Approval to Exdensur, ultra-long acting biologic for Severe Eosinophilic Asthma
GSK announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma characterized by an eosinophilic phenotype. Exdensur stands out as the first ultra-long-acting biologic therapy for severe asthma, designed for twice-yearly dosing, offering patients a more convenient treatment schedule compared with currently available biologics. Clinical
GSK, Novartis, Merck, Gilead, BMS and Amgen cut US drug prices for tariff relief and massive US investment
Six of the world’s largest drugmakers – GSK, Novartis, Merck, Gilead, Bristol Myers Squibb and Amgen – have struck three‑year agreements with the Trump administration to cut US drug prices, expand direct‑to‑patient access and commit tens of billions of dollars to American R&D and manufacturing. Taken together, these deals form the core of a new TrumpRx and “Most Favored Nation” framework that trades tariff relief and policy predictability for visible price cuts on high‑impact
HAS Provides Conditional Reimbursement for Pirtobrutinib and Restricted Use for Upadacitinib | iPharmaCenter
HAS Issues Conditional Reimbursement for JAYPIRCA (Pirtobrutinib) in Relapsed or Refractory Mantle Cell Lymphoma The French Health Authority (HAS) delivered a favorable opinion for reimbursement of JAYPIRCA (pirtobrutinib) only when used as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received a Bruton's tyrosine kinase (BTK) inhibitor and are ineligible for treatment with TECARTUS (brexucabtagene autoleucel). In ot
PBS Adds Zytorvi, First Funded Immunotherapy Option for Australians with Recurrent or Metastatic Nasopharyngeal Carcinoma | iPharmaCenter
Zytorvi PBS listing Toripalimab‑based immunotherapy has been added to Australia’s Pharmaceutical Benefits Scheme (PBS) as the first funded immune checkpoint inhibitor for eligible people with nasopharyngeal carcinoma whose disease has recurred or spread. From 1 December 2025, Zytorvi (toripalimab), a next‑generation PD‑1 inhibitor supplied by Dr. Reddy’s Laboratories under licence from Shanghai Junshi Biosciences, will be reimbursed on the PBS for defined adult nasopharynge
FDA Clears Breyanzi as the First CAR T‑Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma in the US | iPharmaCenter
FDA Greenlights Breyanzi: Pioneering CAR T-Cell Therapy for Marginal Zone Lymphoma The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel) for adults battling relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy. This groundbreaking decision positions Breyanzi as the first CAR T-cell therapy approved in the U.S. for this challenging rare B-cell malignancy, offering new hope to patients with limit
Johnson & Johnson Secures European Commission Approval for IMAAVY (Nipocalimab) to Treat Generalised Myasthenia Gravis
The European Commission has granted Marketing Authorisation to Johnson & Johnson for IMAAVY (nipocalimab), a novel FcRn-blocking antibody therapy designed to help people living with generalised myasthenia gravis (gMG). The approval covers both adult and adolescent patients aged 12 years and older who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies. gMG is a chronic autoimmune neuromuscular disorder that impairs communicati
Sun Pharma Launches ILUMYA in India for Psoriasis Patients | iPharmaCenter
Sun Pharma Launches ILUMYA in India Sun Pharma has unveiled its globally recognized innovative medication, ILUMYA (Tildrakizumab), now available in India for managing moderate-to-severe plaque psoriasis. This advanced biologic therapy has garnered extensive acceptance among dermatologists in the United States and internationally as a reliable and safe option for treating this condition. Also read: Top pharmaceutical companies by revenues in 2025 Long-Term Efficacy of ILUMYA
US FDA Accepts AstraZeneca’s Baxdrostat for Priority Review in Resistant Hypertension
The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca’s New Drug Application (NDA) for baxdrostat under Priority Review , marking a key regulatory milestone for patients with hard‑to‑control or treatment‑resistant hypertension. The application seeks approval for baxdrostat as an add‑on therapy to existing antihypertensive treatments in adult patients whose blood pressure remains inadequately controlled despite standard care. Also read: Top 10 pharmaceutical c
FDA Approves Jaypirca for Relapsed or Refractory CLL/SLL Previously Treated with Covalent BTK Inhibitors | iPharmaCenter
The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly's Jaypirca (pirtobrutinib), making it the first and only non-covalent, reversible Bruton tyrosine kinase (BTK) inhibitor approved to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously received covalent BTK inhibitor therapy. The approval also converts the company's December 2023 accelerated approval into a tradi
Best‑Selling Cancer Drugs 2025: Top 10 Brands, Uses and MOA | Best selling cancer drugs | 2025 | iPharmaCenter
BEST SELLING CANCER DRUGS | TOP ONCOLOGY DRUGS | 2025 Best‑Selling Cancer Drugs 2025: Top 10 Brands, Uses and MOA Rank Brand Revenues 1 Keytruda $ 23.3 billion 2 Darzalex $ 10.4 billion 3 Opdivo $ 7.4 billion 4 Tagrisso $ 5.4 billion 5 Imfinzi $ 4.3 billion 6 Verzenio $ 4.1 billion 7 Kisqali $ 3.5 billion 8 Tecentriq $ 3.3 billion 9 Ibrance $ 3.0 billion 10 Perjeta $ 2.9 billion In 2025, global oncology revenues continue to be dominated by immune checkpoint inhibitors and tar
Top 10 pharmaceutical companies by revenues | 2025 | iPharmaCenter
Top pharmaceutical companies by revenues in 2025. The revenues are captured from the official websites of pharmaceutical companies
Bristol Myers Squibb Extends Cobenfy Trial in Alzheimer’s Psychosis After DMC Recommendation | iPharmaCenter
Bristol Myers Squibb is extending enrollment in its pivotal ADEPT-2 Phase 3 trial of Cobenfy in psychosis associated with Alzheimer’s disease, following a review of site-level data and a recommendation from the study’s independent Data Monitoring Committee (DMC). The company remains blinded to efficacy and safety outcomes from the study. Also read: Top pharmaceutical companies by revenues | 2025 Study continuation after data review During a blinded quality review of ADEPT-
Dual Special Needs Plans (D-SNPs) and Key 2026 Changes: What Dual Eligibles Need to Know During Medicare Enrollment | iPharmaCenter
Dual Special Needs Plans (D-SNPs) are Medicare Advantage plans designed for individuals eligible for both Medicare and Medicaid, offering coordinated coverage that integrates medical, prescription, and supplemental benefits to address complex needs. These plans cover Medicare Parts A, B, and often D alongside Medicaid services like long-term care and behavioral health support, typically with low or no cost-sharing. UnderstandingD-SNPs for Dual Eligibles D-SNPs target "dual el
Eli Lilly Cuts Zepbound Prices on Single‑Dose Vials to Expand Obesity Drug Access in the US | iPharmaCenter
Eli Lilly has cut out‑of‑pocket prices for its obesity drug Zepbound in the United States, lowering the monthly cost of single‑dose vials for patients who pay cash through its LillyDirect platform in an effort to broaden access to tirzepatide. New Zepbound vial pricing and regular prices Under the updated Zepbound Self‑Pay Journey Program on LillyDirect, patients with a valid prescription can now obtain the starter 2.5 mg vial for about 299 dollars per month, down from rou
US–Swiss Tariff Cap Impact on Pharma: How the New US–Swiss Tariff Cap Shapes Pharma and Health Security
Switzerland’s new understanding with the US goes beyond a minor tariff tweak and directly touches the country’s role as a pharma and med‑tech hub. Under a November memorandum of understanding, Washington will cap the country‑specific additional tariff on Swiss goods at 15%, bringing Switzerland into line with the EU and EFTA - while key pharmaceutical products remain largely exempt from the surcharge but under continued scrutiny. What the Switzerland–United States deal doe
NICE’s New £35k/QALY Era: Ripple Effects for Australia’s PBS and Other HTA Markets | NICE Cost Effectiveness Threshold | iPharmaCenter
NICE’s decision to accept higher cost‑per‑QALY ratios is more than a technical parameter change; it reflects a domestic adjustment to a broader bargain the UK has struck with the United States to pay more for branded medicines in return for zero tariffs on British pharmaceutical exports. That combination of trade and health‑policy concessions is likely to shape how other tax‑funded health systems define value, manage finite drug budgets and approach negotiations with global m
NICE increased cost effectiveness threshold from £20,000-£30,000/QALY to £25,000-£35,000/QALY
The UK government announced on December 1, 2025, an increase in the National Institute for Health and Care Excellence (NICE) thresholds used to evaluate new medicines' cost-effectiveness for the National Health Service (NHS). NICE increased cost effectiveness threshold from £20,000-£30,000/QALY to £25,000-£35,000/QALY This adjustment raises the standard range from £20,000 - £30,000 per quality-adjusted life year (QALY) gained to £25,000 - £35,000 per QALY, aiming to foster in
CMS Launches ACCESS Outcome-Aligned Payment Model for High-Burden Chronic Conditions | iPharmaCenter
CMS has introduced the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model, a new 10‑year voluntary payment model in Original Medicare designed to expand technology‑supported care for people living with chronic diseases. The first performance period begins July 1, 2026, with applications due by April 1, 2026; applications submitted after that date will be considered for a January 1, 2027 start. What is the ACCESS Model? The ACCESS Model tests an outcom
FDA Clears Imfinzi as First Perioperative Immunotherapy for Resectable Gastric and GEJ Cancers | iPharmaCenter
FDA approved Imfinzi for perioperative use The U.S. FDA approved Imfinzi (durvalumab) as the first and only perioperative immunotherapy for adults with resectable stage II–IVA gastric and gastroesophageal junction (GEJ) cancers, in combination with FLOT chemotherapy before surgery, continued with FLOT plus Imfinzi after surgery, and followed by Imfinzi monotherapy. The decision was granted Priority Review and evaluated under the FDA’s Project Orbis framework, enabling coordin
EU clears Dupixent as first targeted CSU therapy in over a decade | iPharmaCenter
Dupixent (dupilumab) has been approved in the European Union as the first targeted therapy in more than a decade for chronic spontaneous urticaria (CSU) in patients 12 years and older whose disease remains uncontrolled on standard antihistamines and who are naïve to anti‑IgE therapy. This decision offers a new first‑line biologic option for an estimated 270,000 adolescents and adults in the EU with CSU inadequately controlled by H1 antihistamines. Also read: Top 10 pharmace
FDA Greenlights Kygevvi as Pioneering Therapy for Thymidine Kinase 2 Deficiency in Adults and Kids | iPharmaCenter
The U.S. Food and Drug Administration has endorsed Kygevvi (doxecitine and doxribtimine) oral powder, marking the inaugural authorized remedy for thymidine kinase 2 deficiency (TK2d) among grown-ups and young patients showing signs by age 12 or earlier. Developed by UCB, the drug targets a devastating mitochondrial disorder previously limited to symptom management alone. Grasping TK2d Challenges TK2d represents a scarce inherited condition disrupting mitochondrial DNA produ
China NMPA Approves Pfizer’s Matazisimab (You Ruiting) for Routine Prophylaxis in Hemophilia Patients with Inhibitors | iPharmaCenter
China’s NMPA has approved Pfizer’s matazisimab (You Ruiting) for routine prophylaxis in hemophilia A or B patients with inhibitors, backed by pivotal BASIS data
CMS Projects Billions in Future Savings for Seniors; Maximum Fair Price (MFP) Negotiation Policy Originated Under Biden Administration | iPharmaCenter
The Centers for Medicare & Medicaid Services (CMS) announced a projected net savings of 44%, or $12 billion, on 15 widely used drugs for cancer and other chronic conditions, building on efforts to make prescriptions more affordable for Medicare beneficiaries. Under the Maximum Fair Price (MFP) negotiation policy, established as part of the Biden administration’s Inflation Reduction Act, CMS has negotiated lower prices for high-cost drugs, with these new prices set to take ef
CMS Introduces Proposed Rule to Elevate Quality and Access in Medicare Advantage and Part D | iPharmaCenter
The Centers for Medicare & Medicaid Services (CMS) has proposed new policies for Medicare Advantage (MA) and Medicare Part D plans, aiming to improve quality, boost access, and support innovative benefit designs. The 2027 draft rule details significant changes to the Star Ratings system and invites public comments on how to further modernize Medicare Advantage for both beneficiaries and taxpayers. Also read: Top 10 pharmaceutical companies by revenues Under these proposed u
NICE Approves Autolus’ Obe-cel CAR-T Therapy for Adults with Rare Blood Cancer | iPharmaCenter
Hundreds of adults in England living with a rare and aggressive form of blood cancer could soon access a potentially life-saving therapy, following new guidance from the National Institute for Health and Care Excellence (NICE). NICE has recommended obecabtagene autoleucel, also known as obe-cel or Aucatzyl, for routine NHS use in patients aged 26 and over with relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL). The decision marks an important step forward for
Novartis Receives FDA Approval for Itvisma, Expanding Access to Gene Replacement Therapy for People of All Ages Living with Spinal Muscular Atrophy (SMA)
East Hanover, N.J., [November 24, 2025] - Novartis announced today that the U.S. Food and Drug Administration (FDA) has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, as well as adolescents and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene. This approval makes Itvisma the first and only gene replacement therapy available for this broad population of people a
The Pharma Top 10: Highest Revenue Drugs of 2025 (Official Sales Data & Analysis) | Top selling pharmaceutical drugs | iPharmaCenter
Get the definitive ranking of the top-selling pharmaceutical drugs by global revenue in 2025. See which blockbusters—from Keytruda to the GLP-1 therapies like Ozempic and Mounjaro—are leading the market and driving record sales in Oncology and Immunology.
Germany Signals Major Health System Overhaul as Minister Warken Warns of Growing Deficits | iPharmaCenter
Germany’s Federal Health Minister Nina Warken has signaled significant reforms to the country’s healthcare system, stressing that structural changes are unavoidable as statutory health insurance (GKV) faces mounting financial pressure
FDA Approves KEYTRUDA and KEYTRUDA QLEX in Combination with Padcev as Perioperative Treatment for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer | iPharmaCenter
Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa) in combination with Padcev (enfortumab vedotin) for the perioperative treatment of adults with muscle‑invasive bladder cancer (MIBC) who are ineligible for cisplatin‑based chemotherapy. The regimen includes neoadjuvant therapy before surgery followed by adjuvant treatment after cystectomy. These approvals mark the
Novartis hopes its cancer drugs drive revenues until 2030 | iPharmaCenter
Novartis has released new financial targets, forecasting annual sales growth of 5–6% at constant currencies from 2025 through 2030. This updated mid-term outlook extends the recent upward revision for 2024–2029, now set at a 6% constant currency compound annual growth rate (CAGR). Also read: Top pharmaceutical companies by revenues | 2025 The company anticipates growth in its oncology business to play a key role in driving revenue. Novartis has lifted the peak sales projectio
Roche’s Giredestrant Leads the Way as First Oral SERD to Improve Outcomes in Early Breast Cancer | iPharmaCenter
Roche recently disclosed promising findings from the phase III lidERA Breast Cancer trial, where their experimental oral drug, giredestrant, showed a significant improvement in invasive disease-free survival compared to standard endocrine therapies. This study involved over 4,100 patients diagnosed with early-stage breast cancer characterized by oestrogen receptor-positive (ER+), HER2-negative tumors. The trial’s interim analysis revealed that giredestrant not only met but su
FDA Approves Epkinly in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma | iPharmaCenter
AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab) administered subcutaneously in combination with rituximab and lenalidomide (EPKINLY + R2) for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least one prior systemic therapy. This newly approved regimen is the first and only bispecific antibody combination therapy available for this patient population. The approval was granted base
American College of Rheumatology (ACR) Convergence | Chicago | 2025 | iPharmaCenter
Bristol Myers Squibb Bristol Myers Squibb Unveils Promising Sotyktu Results for Psoriatic Arthritis and Lupus at ACR Conference Bristol Myers Squibb has unveiled new data from late-breaking clinical studies highlighting the promise of Sotyktu (deucravacitinib) in treating both psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE). These findings, from the pivotal Phase 3 POETYK PsA-1 trial and integrated Phase 2 PAISLEY-SLE and long-term extension studies. Psoriati
Novo Nordisk Acquires Akero Therapeutics for $4.7 Billion, Expanding Its MASH Portfolio with First-in-Class FGF21 Analogue
Novo Nordisk, has taken a significant step in expanding its innovative portfolio by announcing the acquisition of Akero Therapeutics, a clinical-stage company specializing in treatments for serious metabolic diseases. This deal, valued at approximately $4.7 billion cash with a potential additional $0.5 billion pending regulatory approval, aims to enhance Novo Nordisk’s pipeline for metabolic dysfunction-associated steatohepatitis (MASH), one of the most rapidly growing obesit
FDA Approves Johnson & Johnson’s Simponi (golimumab) as the First Monthly Maintenance Therapy for Pediatric Ulcerative Colitis
Johnson & Johnson achieved a milestone on October 7, 2025, as the U.S. FDA approved Simponi (golimumab) for pediatric patients aged at least 2 years and weighing at least 15 kg, living with moderately to severely active ulcerative colitis (UC). This regulatory win makes Simponi the first biologic approved for children in this patient group that can be administered on a once-monthly schedule-helping young patients manage a complex disease with far fewer treatment disruptions.
Daiichi Sankyo Advances Breast Cancer Portfolio Expansion with ENHERTU approaval in Japan and DATROWAY's positive study
Daiichi Sankyo has made significant strides in oncology research and care, announcing several developments in the first week of October. The company filed for regulatory approval of Enhertu as a first-line therapy for HER2-positive metastatic breast cancer, combining it with pertuzumab to target aggressive, treatment-resistant tumors. In the U.S., the FDA accepted a supplemental application for a unique regimen offering Enhertu followed by THP before surgery, aiming to im
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