Regulators in the United States have given the green light to a new spinal injection therapy built to slow one of the rarest and most devastating disorders of the nervous system, handing patients and families their first real treatment option after decades with none. The Food and Drug Administration cleared Zanvastro, known by its scientific name zilganersen, for use in both children and adults living with Alexander disease, a genetic condition so uncommon that it touches rou

AbbVie's Etentamig Clears Key Bar in Late Stage Myeloma Study, Cutting Progression Risk by More Than Half AbbVie has shared early but striking findings from a large late stage trial testing its experimental drug etentamig in people battling a form of blood cancer that keeps coming back despite multiple rounds of treatment. The Chicago area drugmaker reported that patients on the therapy responded at nearly double the rate seen in those given currently available treatment opti

Enhertu Combination Approved in EU as First New First-Line Option in a Decade for HER2-Positive Metastatic Breast Cancer The European Commission has approved Enhertu, developed jointly by AstraZeneca and Daiichi Sankyo, in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. This marks the first new first-line treatment approach authorized in the European Union for this patient group in more than ten yea

Cipla Secures Rights to HER2 Bispecific Cancer Drug from Chinese Partner Cipla has entered into an exclusive licensing and supply agreement with Sino Biopharmaceutical’s subsidiary, Chia Tai Tianqing Pharmaceutical Group, for a promising cancer treatment known as Rolditamig Deuderuxtecan, also called TQB2102. The deal grants Cipla exclusive rights to develop and sell this HER2-targeted therapy across India, South Africa, and five additional emerging markets. A Dual-Target App

CRISPR Therapeutics’ CTX310 Shows Durable Lipid Control One Year After Treatment CRISPR Therapeutics presented new one-year follow-up results of investigational gene editing therapy CTX310 produced lasting reductions in a protein linked to cholesterol and triglyceride buildup. A Gene Editing Approach to Lipid Disorders CTX310 is an investigational in vivo CRISPR-Cas9 therapy designed to edit a gene called ANGPTL3 inside liver cells. This gene plays a central role in regulatin

The constitution of India ensures the "right to health" for every citizen. It is the responsibility of the state governments to provide health care services to citizens. The funding for healthcare in India is 3.3% of GDP and is continuously decreasing since (3.75% in 2013). The infant mortality rate was reduced from 88/1,000 in 1990 to 32/1,000 in 2020. The maternal mortality rate was reduced from 556/100,000 to 113/100,000 during 2016-18. Also read: Expected best selling dr

The U.S. Food and Drug Administration has approved MIMRYLO, also known as rusfertide, for the treatment of erythrocytosis in adults with polycythemia vera, a rare and chronic blood cancer. The decision introduces the first hepcidin mimetic medicine authorized for this condition, offering patients a new mechanism of action beyond the therapies currently available. A Long-Standing Challenge in PV Management Polycythemia vera affects an estimated 90,000 people in the United Stat

The U.S. Food and Drug Administration has approved RASONQUE, also known as daraxonrasib, as a once-daily oral treatment for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent chemotherapy. The decision marks the first approval of a broad RAS-targeted medicine for this disease. RASONQUE belongs to a new class of RAS(ON) multi-selective and mutant-selective inhibitors designed to suppre

Rexobin Approved for Pustular Psoriasis Flares The NMPA has authorized Rexobin injection, submitted by Shanghai Huatai Biological Pharmacy, through the priority review pathway. The treatment is intended for adults weighing at least 40 kilograms who experience flare-ups of generalized pustular psoriasis. The approval introduces an additional therapy for patients affected by this rare and severe inflammatory skin condition. The authorization was announced on July 29, 2026. Teng

The U.S. Food and Drug Administration has approved IMAAVY, also known as nipocalimab, for adults and children aged 12 years and older with warm autoimmune hemolytic anemia who are currently receiving or have previously received corticosteroids. The decision gives patients with this rare and potentially life-threatening blood disorder the first treatment specifically approved for warm autoimmune hemolytic anemia. Johnson and Johnson said the approval followed the agency’s prio

Japan Approves Hibsago for Chronic Hepatitis B Japan has cleared GSK’s Hibsago, also known as bepirovirsen, for adults with chronic hepatitis B who have already received at least six months of nucleos(t)ide analogue treatment and meet specified viral-marker criteria. The decision marks the therapy’s first approval anywhere in the world and introduces Japan’s first treatment authorised to pursue a functional cure for chronic hepatitis B. The Ministry of Health, Labour and Welf

MHLW JAPAN | CHUIKYO DRUG PRICING | August 13, 2026 Brand INN Company Dosage Indication Calculated Drug Price Calculation Method and premiums achieved Juxtapid Capsules for Pediatric Use Lomitapide mesylate Recordati Rare Diseases 2mg per capsule Homozygous familial hypercholesterolemia ¥72,127.50 Inter-standard adjustment Child surcharge = 5%, Marvelon Desogestrel / Ethinylestradiol Organon 1 tablet Dysmenorrhea ¥276.90 Similar drug efficacy comparison method (I) Usefulness

Eli Lilly’s Once-Weekly Insulin Efsitora Alfa Gains NICE Support for Type 2 Diabetes NICE has recommended insulin efsitora alfa, developed by Eli Lilly under the brand name Onswik. NICE said clinical evidence indicates that insulin efsitora alfa provides blood glucose control comparable to two established long-acting insulins, insulin degludec and insulin glargine. The weekly medicine could therefore offer patients a less frequent dosing schedule without compromising the leve

The US Food and Drug Administration has cleared Regeneron's Pasatru (garetosmab) for adults with fibrodysplasia ossificans progressiva, marking the second approved treatment for this ultra-rare condition and the first to show meaningful reductions in both new heterotopic ossification lesions and clinician-assessed flare-ups. What changed for FOP patients? Fibrodysplasia ossificans progressiva is a rare genetic disease in which soft tissues such as muscle, tendon and ligament

Merck and Moderna Report Positive Phase 3 Results for Personalized Melanoma Therapy Merck and Moderna have announced positive topline results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene in combination with pembrolizumab as adjuvant treatment for patients with completely resected stage IIB to IV melanoma. The investigational regimen met the study’s primary endpoint of recurrence-free survival and a key secondary endpoint measuring the time patients rema

South Korea’s HIRA to Advise Drugmakers on Faster Rare Disease Listings South Korea’s Health Insurance Review and Assessment Service is preparing a consultation meeting for pharmaceutical companies as part of a pilot program intended to speed up insurance coverage for rare disease treatments. The meeting is designed to help companies understand how the accelerated listing pathway works and how they can apply for coverage for individual products. HIRA and NHIS Join Effort Seve

The National Institute for Health and Care Excellence has supported several new treatment pathways covering hereditary angioedema, mantle cell lymphoma, and chronic lymphocytic leukaemia. The recommendations could expand access to donidalorsen for eligible patients with recurrent hereditary angioedema and introduce two acalabrutinib-based treatment approaches for adults with previously untreated blood cancers. Donidalorsen Recommended for Hereditary Angioedema NICE has recomm

The U.S. Food and Drug Administration has granted accelerated approval to Genglycos, a one-time gene therapy developed by Ultragenyx Pharmaceutical for adults and children aged eight years and older with glycogen storage disease type Ia. The approval makes Genglycos the first FDA-authorized treatment for this rare inherited metabolic disorder. It is also designed to address the genetic cause of the disease rather than focusing only on managing its symptoms. What causes glycog

AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) met its primary endpoint in the DESTINY-Lung04 study, showing a clear and meaningful extension of progression-free survival versus current first-line therapy in patients with HER2-mutant advanced non-squamous non-small cell lung cancer. In parallel, HUTCHMED announced that the SAFFRON trial met both its progression-free and overall survival endpoints for Tagrisso (osimertinib) plus Orpathys (savolit

Rank Brand Indications H1 Revenues (in billions) 2026 Revenues (in billions) 1 Dupixent Atopic dermatitis, Asthma, CRSwNP, Eosinophilic esophagitis, Prurigo nodularis $10.7 2 Skyrizi Plaque psoriasis, Psoriatic arthritis, Crohn's disease, Ulcerative colitis $10.0 3 Rinvoq Rheumatoid arthritis, Psoriatic arthritis, Atopic dermatitis, Ulcerative colitis, Crohn's disease, Ankylosing spondylitis, nr-axSpA $4.6 4 Tremfya Plaque psoriasis, Psoriatic arthritis, Ulcerative colitis $3

BEST SELLING CANCER DRUGS | TOP ONCOLOGY DRUGS | 2025 BEST SELLING CANCER DRUGS 2025 Rank Brand Company Indications Revenues $ billion 1 Keytruda Merck Melanoma, NSCLC, HNSCC, Hodgkin Lymphoma, Urothelial Cancer, RCC, HCC and several other cancers $31.7 2 Darzalex Johnson and Johnson Multiple myeloma $14.5 3 Opdivo Bristol Myers Squibb Melanoma, NSCLC, Hodgkin Lymphoma, Urothelial Cancer, RCC, HCC and several other cancers $10.0 4 Tagrisso AstraZeneca EGFR positive NSCLC $7.2

A new CVS Caremark and Employee Benefit News survey shows that employers are increasingly relying on pharmacy benefit managers to control prescription drug spending, improve access to specialty medicines, and manage the growing cost of GLP-1 treatments. The State of Pharmacy Management Survey found that employers see three major opportunities for pharmacy benefit management: expanding biosimilar use, developing sustainable GLP-1 strategies, and using digital tools to create a

The Saudi Food and Drug Authority has introduced the New Accelerator Program for Drugs in Rare Diseases, known as NADR, to support the development, registration, and faster availability of medicines for rare conditions. The initiative is intended to strengthen cooperation among regulators, researchers, pharmaceutical companies, and innovators while helping eligible patients gain earlier access to promising treatments. Dedicated Framework for Rare Disease Medicines The NADR pr

The Saudi Food and Drug Authority has become the first regulatory agency worldwide to approve iberdomide for adults with relapsed or refractory multiple myeloma. The treatment, marketed as ZENBEXUS, is authorized for use alongside daratumumab and dexamethasone in patients whose disease has returned or no longer responds adequately to earlier treatment. The SFDA announced the decision on August 11, 2026. Approval Based on Phase 3 Evidence The registration was supported by resu

The US Food and Drug Administration has granted accelerated approval to Zenbexus, also known as iberdomide, in combination with daratumumab and hyaluronidase plus dexamethasone for adults with multiple myeloma previously treated with at least one regimen containing both a proteasome inhibitor and an immunomodulatory medicine. The approval is based on findings from the Phase 3 EXCALIBER-RRMM study, which evaluated the Zenbexus combination in patients with relapsed or refractor

Sl No Brand Q1 H1 9M Total 1 Johnson and Johnson $24.1 $49.4 2 Roche $18.8 $45.5 3 Eli Lilly $19.8 $42.8 4 AbbVie $15.0 $32.0 5 AstraZeneca $15.3 $30.7 6 Pfizer $14.4 $29.5 7 Merck $14.3 $29.1 8 Novartis $13.1 $27.5 9 Novo Nordisk $15.2 $27.0 10 Sanofi $12.4 $25.3 The first quarter of 2026 confirmed that GLP-1 drugs are still rewriting the global pharmaceutical revenue rankings. Eli Lilly posted $19.8 billion revenues, the fastest rate among the top 10 companies, driven entir

Top pharmaceutical companies by revenues in 2025. The revenues are captured from the official websites of pharmaceutical companies

AIFA Forms Expert Panels to Support Oncology and Hematology Decision The Italian Medicines Agency has created two specialist advisory groups focused on cancer care and blood-related malignancies. The initiative is designed to strengthen scientific cooperation with Italy’s leading medical societies and provide additional expertise to AIFA’s Scientific and Economic Commission for Medicines and internal departments. Both panels will operate under the coordination of Pierluigi Ru

Ocrelizumab Secures Expanded Approval for Pediatric Multiple Sclerosis Roche has received authorization to expand the use of ocrelizumab for children and adolescents aged 12 and older with relapsing-remitting multiple sclerosis. Patients must weigh at least 40 kilograms to qualify. Pediatric MS is rare but highly inflammatory and can severely affect cognitive and social development. This regulatory green light relies on the Phase III OPERETTA 2 trial, which proved the monoclo

Italy’s pharmaceutical market recorded higher spending in 2025 despite a modest decline in the number of medicine packs dispensed, according to the latest OsMed report from the Italian Medicines Agency. Total pharmaceutical expenditure reached €39.3 billion, representing a 6% increase from 2024. Public funding accounted for €28.4 billion, up 5.8% year over year, and represented 72.2% of total medicine spending and approximately one-fifth of overall public healthcare expenditu

The National Institute for Health and Care Excellence has endorsed acalabrutinib as an additional treatment option for adults newly diagnosed with mantle cell lymphoma or chronic lymphocytic leukaemia in England. The decision could expand access to targeted therapy for hundreds of patients, including approximately 440 people with previously untreated chronic lymphocytic leukaemia. Longer Disease Control in Mantle Cell Lymphoma Mantle cell lymphoma is an uncommon and fast-grow

Top 10 healthcare companies by revenues | 2026 Rank Company Q1 H1 9M 2026 revenues 1 United Health Group $111.7 $223.7 2 CVS Health $100.4 $206.5 3 Cigna Group $68.5 $140.0 4 Centene $49.9 $103.5 5 Elevance Health $49.5 $99.3 6 Humana $39.6 $80.5 7 Kaiser Permanente $34.6 8 HCA Healthcare $19.1 $39.3 9 Molina Healthcare $10.8 $20.4 10 Tenet Healthcare $5.4 $11.0 United Health Group Q1 REVENUES: UnitedHealth Group reported first-quarter 2026 revenues of $111.7 billion, repres

The U.S. Food and Drug Administration has authorized Pluvicto for use with standard hormone blocking regimens in adults with PSMA positive metastatic hormone sensitive prostate cancer. The decision allows clinicians to combine the radioligand therapy with androgen deprivation and androgen receptor pathway inhibitors in patients whose disease is still hormone sensitive, significantly increasing the group eligible for this targeted approach. PSMAddition data underpin the label

AstraZeneca and Daiichi Sankyo have secured European Commission approval for Datroway (datopotamab deruxtecan) as a first-line monotherapy for adult patients diagnosed with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 inhibitor treatments. This regulatory milestone follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Also read: UK greenlights aficamten: thous

England is set to offer a new oral treatment to an estimated 6,600 adults living with obstructive hypertrophic cardiomyopathy after regulators and health economists moved in tandem to clear the drug for NHS use. The move follows simultaneous marketing authorisation from the MHRA and a positive recommendation from NICE, paving the way for rapid rollout across the country. What this approval means for patients? Obstructive hypertrophic cardiomyopathy thickens and stiffens the h

UnitedHealth Group is pouring fresh resources into a Tennessee-led effort to bring preventive and chronic care services closer to residents, especially in rural areas. A new $4 million commitment will help grow the University of Tennessee Health Sciences’ health hub network from five sites to 13 by the end of 2027, with the goal of reaching about 200,000 people across the state. What the funding covers? The support comes through the United Health Foundation, paired with techn

The European Commission has officially granted marketing authorization for AbbVie’s RINVOQ (upadacitinib) for the treatment of severe alopecia areata in patients 12 years of age and older. This approval encompasses both the 15 mg and 30 mg once-daily oral dosing regimens, marking a significant expansion for the JAK inhibitor in the autoimmune therapeutic space. The drug is indicated for individuals experiencing significant hair loss, a condition frequently associated with pro

AstraZeneca Pharma India secured a significant regulatory expansion from the Central Drugs Standard Control Organisation (CDSCO) for trastuzumab deruxtecan. The approval covers the 100 mg/5 mL presentation of the drug for use in a neoadjuvant regimen, administered prior to surgical intervention, for adult patients diagnosed with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer. This treatment protocol involves the administration of trastuzumab deruxtecan followed

Johnson & Johnson has finalized its acquisition of Firefly Bio while establishing a major alliance with Sail Biomedicines. These strategic moves strengthen the healthcare giant's presence in precision oncology and next-generation immunology. Firefly Bio Buyout Strengthens Solid Tumor Strategy The finalized purchase of Firefly Bio cost $1 billion in cash, integrating the target firm's proprietary degrader antibody conjugate platform into the corporate pipeline. This technology

The U.S. Food and Drug Administration has granted approval to Otsuka Pharmaceutical for SIMTRIYO (centanafadine), marking the first regulatory clearance for a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) intended for the treatment of attention-deficit/hyperactivity disorder (ADHD). Indicated for pediatric patients aged 6 years and older weighing at least 20kg, as well as adult patients, the medication is formulated as a once-daily, extended-release capsule.

Key Regulatory Proposals Sanofi has officially terminated its clinical development program for amlitelimab, an OX40-ligand targeting monoclonal antibody previously intended for the treatment of moderate-to-severe atopic dermatitis. Following a comprehensive strategic pipeline review, the company has elected to abandon all plans for global regulatory submissions for this indication. Sanofi is currently initiating a structured wind-down of all ongoing clinical trials, including

Takeda China has received approval from the National Medical Products Administration (NMPA) for Orzeyful (oveporexton) as a treatment for Narcolepsy Type 1 (NT1). Also read: Germany Enacts 2026 Healthcare Reform to Curb Statutory Insurance Spending This authorization establishes Orzeyful as the first oral orexin receptor 2 (OX2R)-selective agonist in the Chinese market and represents the first therapy approved specifically to address the underlying physiological cause of the

The United States Food and Drug Administration has granted approval for Jideytro, (zidesamtinib), as a targeted therapy for adult patients facing locally advanced or metastatic ROS1 positive non small cell lung cancer. This clearance applies specifically to individuals who have already undergone treatment with a prior ROS1 kinase inhibitor. Regulatory authorization arrived ahead of the anticipated September deadline following prior Breakthrough Therapy and Orphan Drug recogni

The Central Drugs Standard Control Organisation (CDSCO) has officially authorized the marketing of Qdenga, a dengue tetravalent vaccine manufactured by Takeda, marking a significant development in India’s public health strategy. The approval introduces the first preventative immunologic tool against dengue fever in the country. This regulatory milestone follows a comprehensive evaluation of the vaccine’s safety, quality, and efficacy under the provisions of the Drugs and Cosm

On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a new draft guidance that fills in critical operational details for the Inflation Reduction Act’s drug price negotiation program. The document explains how pharmaceutical manufacturers will be expected to implement Medicare’s negotiated prices when they go live in 2028, with specific expectations for both pharmacy-dispensed and physician-administered therapies. For life sciences companies, this guidan

The Centers for Medicare & Medicaid Services (CMS) has unveiled a comprehensive, three-pillar strategy aimed at fundamentally restructuring Original Medicare (OM) by transitioning away from traditional, fragmented fee-for-service payment models. The new framework seeks to optimize spending efficiency, expand patient-centric decision-making, and strengthen provider accountability within the Medicare Shared Savings Program. This initiative reflects the agency’s intensified focu

Leqembi Real-World LEADER Study validates the Real-World Performance New interim findings from the LEADER study, a three-year retrospective analysis of Leqembi (lecanemab), indicate sustained therapeutic efficacy in a real-world clinical setting. Analyzing data from 432 patients across 13 U.S. clinical sites, the study reports that 82.5% of individuals with early-stage Alzheimer’s disease (AD) experienced disease stabilization or cognitive improvement after an average treatme

Merck has secured FDA approval for LIPFENDRA (enlicitide) 20 mg tablets, establishing the first oral PCSK9 inhibitor available for the management of hypercholesterolemia. Approved as an adjunct to diet and exercise, the macrocyclic peptide is indicated for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). Also read: CMS Proposes Major Medicare Overhaul: Shifting Toward Accountable Care and Value-Based Payments The therap

Takeda Reports Positive Phase 3 Results for Zasocitinib in Plaque Psoriasis Takeda Pharmaceutical has announced positive results from its pivotal Phase 3 LATITUDE PsO 3001 and 3002 clinical trials, establishing its selective TYK2 inhibitor, zasocitinib, as a high-efficacy oral candidate for moderate-to-severe plaque psoriasis. With approximately 70 percent of participants achieving a static Physician Global Assessment (sPGA) score of clear or almost clear by the 16-week mark,

Eli Lilly and Company has announced a definitive agreement to acquire clinical-stage biopharmaceutical firm AtaiBeckley in a transaction valued at up to $3.8 billion. The acquisition aims to significantly expand Lilly’s neuroscience pipeline by integrating advanced neuroplastogen therapies designed to treat complex and treatment-resistant mental health conditions. Key Regulatory Proposals The financial terms of the agreement include an initial $2.8 billion upfront cash paymen