FDA Approves Otsuka’s SIMTRIYO as First-in-Class NDSRI for ADHD
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.
5 days ago2 min read
FDA Approves First Oral PCSK9 Inhibitor, Signaling Shift in Dyslipidemia Treatment
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
Jul 172 min read
FDA Grants Landmark Approval for REVTORPYK: A New Standard for PIK3CA Wild-Type Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Celcuity’s REVTORPYK (gedatolisib) for the treatment of HR+/HER2- metastatic breast cancer patients who do not possess a PIK3CA mutation. As the first therapy capable of inhibiting all class I PI3K isoforms (α, β, δ, γ) in conjunction with both mTORC1 and mTORC2 complexes, REVTORPYK introduces a novel mechanism of action for a patient population that accounts for approximately 42% of all HR+/HER2- diagnoses. Also read:
Jul 152 min read
FDA Approval of Sarclisa Escena Marks Shift Toward Subcutaneous Oncology Delivery | iPharmaCenter
The U.S. Food and Drug Administration (FDA) has officially approved the subcutaneous formulation of Sarclisa (isatuximab), branded as Escena, establishing it as the first anticancer therapy to utilize an on-body injector (OBI). Also read: CVS Pharmacy Joins Medicare GLP-1 Bridge and Scales Weight‑Loss Access Across the U.S Powered by the CirCLIQ platform, this new delivery method offers patients the option for either manual subcutaneous administration or automated, hands-free
Jul 142 min read
FDA Approves KEYTRUDA-Padcev Combo as First Perioperative Standard for Muscle-Invasive Bladder Cancer
The FDA has officially approved a novel perioperative treatment regimen for muscle-invasive bladder cancer (MIBC), authorizing the combination of Merck’s KEYTRUDA—including the new subcutaneous formulation, KEYTRUDA QLEX, with Pfizer and Astellas’ antibody-drug conjugate (ADC), Padcev. This regulatory milestone represents the first instance of a PD-1 inhibitor and ADC combination being approved for MIBC, irrespective of a patient’s eligibility for cisplatin-based chemotherapy
Jul 112 min read