pharma news
Dec 02, 2025
Novo Nordisk Seeks FDA Approval for Higher-Dose 7.2 mg WEGOVY Injection; Ascendis Pharma Granted FDA Review Extension for TransCon CNP in Children with Achondroplasia; VOYXACT Receives FDA Fast-Track Approval for Treatment of High-Risk Primary IgAN; Sarepta Begins Next ENDEAVOR Cohort Focused on Immunosuppressive Optimization for ELEVIDYS in Advanced DMD; IMFINZI Gains U.S. Approval as the Sole Perioperative Immunotherapy for Early-Stage Gastric and GEJ Cancer
Novo Nordisk Submits FDA Application for 7.2 mg Dose of WEGOVY Injection Novo Nordisk has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a higher, investigational 7.2 mg dose of its once-weekly semaglutide injection, marketed as WEGOVY, f...
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Nov 25, 2025
Novartis Secures FDA Approval for ITVISMA; Kelun-Biotech’s Phase III Study Shows Sac-TMT + Keytruda Achieves Primary Endpoint in First-Line PD-L1-Positive NSCLC; Evoke Phase 3 Trials Failed to Show a Statistically Significant Impact on Alzheimer’s Disease Progression; Sangamo Therapeutics Gets FDA Nod for Rolling BLA Submission of ST-920 in Fabry Disease; Bayer’s HYRNUO Receives FDA Accelerated Approval for Previously Treated HER2-mutant NSCLC
Novartis Secures FDA Approval of ITVISMA for Children Two Years and Older, Teens, and Adults with Spinal Muscular Atrophy (SMA) Novartis has announced a significant expansion in the treatment landscape for Spinal Muscular Atrophy (SMA) with the FDA approval of ITVISMA (onasemnogene abeparvovec-brve). This one-ti...
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Nov 18, 2025
Sarepta Secures FDA Approval of Revised Prescribing Information for ELEVIDYS; Merck to Acquire Cidara Therapeutics; BMS & J&J Halt Milvexian Phase III in ACS After Interim Review; Kura Oncology & Kyowa Kirin Win FDA Green Light for KOMZIFTI in NPM1-Mutated AML; Novartis’ Phase III KLU156 (GanLum) Trial Hits Primary Endpoint
FDA Approves Major Safety and Indication Updates for Sarepta's ELEVIDYS Gene Therapy Sarepta Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved significant updates to the prescribing information for its Duchenne muscular dystrophy (DMD) gene therapy, ELEVIDYS (delandistrogene mo...
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Nov 11, 2025
Cogent Biosciences’ Bezuclastinib Phase 3 PEAK Trial Positive Results for GIST; Domain Therapeutics Begins Phase I/II Trial of CCR8 Inhibitor DT-7012 in Solid Tumors; Anaptys Reports Negative Phase 2 Outcomes for Rosnilimab in Ulcerative Colitis; QOL Medical Strikes Deal to Acquire Evoke Pharma for $11 Cash Per Share; Eledon Pharmaceuticals, Inc. Unveils Phase 2 BESTOW Trial Data for Tegoprubart in Kidney Transplant Rejection Prevention at ASN Kidney Week 2025
Cogent Biosciences Announces Positive Outcomes from the Phase 3 PEAK Trial of Bezuclastinib in Gastrointestinal Stromal Tumors Cogent Biosciences, Inc. announced positive topline results from its Phase 3 PEAK trial evaluating bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastroin...
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Nov 04, 2025
Intensity Therapeutics Publishes Compelling Clinical Data for INT230-6 in Advanced Cancers; UCB Wins FDA Approval for KYGEVVI for Rare Mitochondrial Disease TK2d; BrainXell Therapeutics Unveils Promising Preclinical Data for iPSC-Derived Neuronal Therapy in Parkinson’s Disease; CARsgen Therapeutics Reports Encouraging Clinical Data for Allogeneic CAR-T Products in Hematologic Malignancies; Novo Nordisk’s $9 Billion Counterbid for Metsera Ignites Landmark Obesity Drug Market Battle
Intensity Therapeutics Publishes Compelling Clinical Data for INT230-6 in Advanced Cancers Intensity Therapeutics, Inc. (Nasdaq: INTS) announced the publication of its Phase 1/2 clinical results for INT230-6. The comprehensive study evaluated the intratumoral therapy's safety, efficacy, and mechanism of action a...
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Oct 28, 2025
Syndax Pharmaceuticals Receives FDA Approval for REVUFORJ; FDA Approves BLENREP for Adults with Relapsed/Refractory Multiple Myeloma; Novartis to Acquire Avidity for $12 Billion; BridgeBio Reports Positive Phase 3 Results for Small Molecule BBP-418 in LGMD2I/R9 FORTIFY Study; Eli Lilly to Acquire Adverum Biotechnologies
Syndax Pharmaceuticals Receives Approval for REVUFORJ from the FDA Syndax Pharmaceuticals announced that the FDA has approved REVUFORJ (revumenib) for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and old...
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Oct 21, 2025
FDA Approves Genentech’s GAZYVA for Lupus Nephritis; Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment; FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma; Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN; Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps
FDA Approves Genentech’s GAZYVA for Lupus Nephritis Genentech, a member of the Roche Group, announced that the FDA has approved GAZYVA (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval is supported by data from the Phase II NOBILITY and P...
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Oct 14, 2025
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade Boehringer Ingelheim’s JASCAYD (nerandomilast) has received FDA approval as an oral treatment for adults with idiopathic pulmonary fibrosis (IPF), marking the first new therapy for the condition in over a decade. JASCAYD is the first and...
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Oct 07, 2025
Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma; Eccogene Gets FDA Nod to Begin Phase IIa MOSAIC Trial of ECC4703 + ECC0509 in MASH; Orca Bio’s Orca-T Earns FDA Priority Review for Hematologic Malignancies; Alto Neuroscience Gains FDA Fast Track for ALTO-101 in Cognitive Impairment Linked to Schizophrenia; Taysha Gene Therapies Wins FDA Breakthrough Therapy Status for TSHA-102 in Rett Syndrome
Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma Aminex Therapeutics, Inc., a clinical-stage biotechnology company developing novel cancer therapies, announced that the FDA has granted Orphan Drug Designation (ODD) to AMXT 1501 in combination with difluoromethylornith...
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Sep 30, 2025
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year Regeneron Pharmaceuticals, Inc. announced that the FDA has approved EVKEEZA (evinacumab-dgnb) ANGPTL3 antibody, for children aged 1 to under 5 years with homozygous familial hypercholesterolemia (HoFH). This expands the indication from...
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