pharma news
Jul 08, 2025
Merck’s WINREVAIR Granted FDA Priority Review for Pulmonary Arterial Hypertension; KalVista’s EKTERLY Approved by FDA as First Oral On-Demand Therapy for Hereditary Angioedema; Fujifilm’s FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer; Mustang Bio’s MB-101 Granted FDA Orphan Drug Designation for Glioblastoma and Astrocytomas; Denali’s Tividenofusp Alfa Accepted for FDA Priority Review for Hunter Syndrome
Merck's WINREVAIR Gets FDA Priority Review for Pulmonary Arterial Hypertension Merck, also known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for WINREVAIR (sotatercept-csrk). The application seeks to ...
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Jul 01, 2025
Sobi’s GAMIFANT Approved by FDA as First Treatment for Macrophage Activation Syndrome in Still’s Disease; GSK Cuts RTS,S Malaria Vaccine Price for Children in Endemic Regions to Under $5; Schrödinger’s SGR-1505 Receives FDA Fast Track Designation for Relapsed/Refractory Waldenström Macroglobulinemia; Ultragenyx’s GTX-102 Granted FDA Breakthrough Therapy Designation for Angelman Syndrome; Eli Lilly’s AMYVID Label Updated by FDA to Support Alzheimer’s Disease Diagnosis
FDA Approves Sobi’s GAMIFANT as the First Treatment for Macrophage Activation Syndrome in Still’s Disease In a major advancement for rare inflammatory conditions, the FDA has approved GAMIFANT (emapalumab-lzsg) for the treatment of hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MA...
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Jun 24, 2025
Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma; Gilead’s YEZTUGO Becomes First FDA-Approved HIV Prevention with 6-Month Protection; FDA Reviewing Incyte’s OPZELURA for Pediatric Atopic Dermatitis (Ages 2–11); Archeus Technologies Receives FDA Clearance for Prostate Cancer Therapy ART-101; Cycle Pharmaceuticals’ HARLIKU Gets First FDA Approval for Alkaptonuria
Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma Incyte has announced that the FDA has approved MONJUVI (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). This makes it the f...
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Jun 17, 2025
Celltrion Announces FDA Nod for New STEQEYMA Presentation to Broaden Pediatric Use; CSL’s ANDEMBRY Gets FDA Nod as First Factor XIIa Inhibitor for Hereditary Angioedema; Ocugen’s OCU410ST Cleared by FDA to Begin Phase II/III Trial in Stargardt Disease; Milestone Pharmaceuticals Submits FDA Response for CARDAMYST in PSVT; AbbVie’s MAVYRET Approved by FDA as First and Only Therapy for Acute Hepatitis C
Celltrion Announces FDA Approval of New STEQEYMA Presentation, Expanding Pediatric Dosing Options Celltrion, Inc. has announced that the FDA has approved an additional presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, in a 45mg/0.5mL single-dose vial for subcutaneous injection. This new formu...
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Jun 10, 2025
Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants
Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS Amylyx Pharmaceuticals announced that the FDA has granted Fast Track designation to its investigational antisense oligonucleotide (ASO), AMX0114, for the treatment of amyotrophic lateral sclerosis (ALS). The candidate targets calpain-2...
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Jun 03, 2025
Beam’s BEAM-302 Earns FDA Orphan Drug Tag for AATD; Incannex’s IHL-42X Moves to Phase III After FDA Protocol OK; Kura and Kyowa Kirin’s Ziftomenib Gets FDA Priority Review in NPM1-Mutant AML; GSK’s Linerixibat NDA Accepted by FDA for PBC-Linked Pruritus; Ascendis’ TransCon CNP Granted FDA Priority Review for Achondroplasia
Beam Therapeutics Secures FDA Orphan Drug Designation for BEAM-302 in AATD Beam Therapeutics Inc. announced that the FDA has granted Orphan Drug Designation to its investigational therapy, BEAM-302, for the treatment of alpha-1 antitrypsin deficiency (AATD). BEAM-302 is a liver-targeting lipid nanoparticle (LNP)...
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May 27, 2025
Gilead’s TRODELVY Shows PFS Benefit in 1L Metastatic TNBC; Otsuka’s Sibeprenlimab Gets FDA Priority Review for IgA Nephropathy; Liquidia Wins FDA Nod for YUTREPIA in PAH and PH-ILD; GSK’s BLENREP Combos Get CHMP Backing in Myeloma; Relief Therapeutics Receives FDA Rare Pediatric Disease Tag for RLF-TD011
Gilead’s TRODELVY Demonstrates Significant PFS Benefit in First-Line Metastatic TNBC in ASCENT-03 Trial Gilead Sciences has announced positive topline results from the Phase III ASCENT-03 trial of TRODELVY (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) patients who ar...
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May 20, 2025
Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+
Incyte’s ZYNYZ Approved by FDA as First-Line Treatment for Advanced Anal Cancer The FDA approved ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor developed by Incyte, for the treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The approval incl...
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May 13, 2025
Eli Lilly’s ZEPBOUND Surpasses WEGOVY in SURMOUNT-5 Trial; Verastem Oncology Secures FDA Approval for AVMAPKI + FAKZYNJA in KRAS-Mutant Ovarian Cancer; Thermosome Gains Orphan Drug Designation for THE001; Beam Therapeutics Receives RMAT Status for BEAM-302 in AATD; Capsida Biotherapeutics Gets IND Clearance for STXBP1 Gene Therapy
Eli Lilly’s ZEPBOUND Outperforms WEGOVY in SURMOUNT-5 Trial Eli Lilly and Company released detailed results from the Phase IIIb SURMOUNT-5 clinical trial, showing that ZEPBOUND (tirzepatide) significantly outperformed WEGOVY (semaglutide) in weight loss among adults with obesity or overweight and at least one we...
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May 06, 2025
Abeona Secures FDA Nod for ZEVASKYN, the First Gene Therapy for RDEB; AbbVie Gains FDA Approval for RINVOQ in Giant Cell Arteritis; Lantern Pharma Advances LP-184 with IND Clearance for TNBC Trial; Ichnos Glenmark Earns FDA Fast Track for ISB 2001 in Multiple Myeloma; Rezolute Wins Breakthrough Therapy Designation for Ersodetug in Tumor-Induced Hypoglycemia
FDA Approves Abeona’s ZEVASKYN as First Cell-Based Gene Therapy for RDEB The FDA approved Abeona Therapeutics’ ZEVASKYN (prademagene zamikeracel, or pz-cel), the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is d...
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