pharma news
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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Sep 23, 2025
Merck Wins FDA Approval for KEYTRUDA QLEX for Subcutaneous Use in Adults With Solid Tumors; Incyte Gains FDA Nod for OPZELURA Cream in Children Aged 2–11 With Atopic Dermatitis; Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome; MavriX Bio Secures FDA Fast Track for MVX-220 Gene Therapy in Angelman Syndrome; Biocon Biologics Gets FDA Approval for Denosumab Biosimilars BOSAYA and AUKELSO
FDA Approves Merck’s KEYTRUDA QLEX for Subcutaneous Use Across Multiple Solid Tumors Merck announced that the FDA has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous administration in adults across most of KEYTRUDA’s approved solid tumor indications. Unlike the intravenous...
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Sep 16, 2025
Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia
Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib/II clinical trials in patients with chronic hepatitis B (CHB). The ...
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Sep 09, 2025
NeuroNOS’ BA-101 Granted FDA Orphan Drug Status for Glioblastoma; Takeda’s VONVENDI Approval Expanded for Von Willebrand Disease in Adults and Children; Telix Gains FDA Nod on Resubmission Pathway for TLX101-CDx NDA; Saol Therapeutics Receives FDA CRL for SL1009 in Pyruvate Dehydrogenase Complex Deficiency; FDA Grants Breakthrough Therapy Designation to Boehringer’s HERNEXEOS for HER2-Mutant Advanced NSCLC
NeuroNOS Secures FDA Orphan Drug Designation for BA-101 in Glioblastoma NeuroNOS, a biopharmaceutical company specializing in neurological disorders and neuro-oncology and a subsidiary of Beyond Air, announced that the FDA has granted Orphan Drug Designation (ODD) to its lead investigational therapy, BA-101, for...
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Sep 02, 2025
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals’ VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi’s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance do...
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Aug 26, 2025
Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia
Madrigal Wins EU Approval For REZDIFFRA In MASH With Liver Fibrosis Madrigal Pharmaceuticals announced that the European Commission (EC) has granted conditional marketing authorization for REZDIFFRA, the first and only approved therapy in the European Union (EU) for adults with noncirrhotic metabolic dysfunction...
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Aug 19, 2025
Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis; Tonix’s Tonmya Becomes First FDA-Approved Fibromyalgia Treatment in Over 15 Years; FDA Extends BLA Review for REGENXBIO’s RGX-121 in MPS II Patients; SystImmune’s Izalontamab Brengitecan (EGFRxHER3 ADC) Gets FDA Breakthrough Designation for EGFR-Mutated NSCLC; Soligenix Granted FDA Orphan Drug Status to SGX945 for Behçet’s Disease Therapy Following Phase II Success
Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has granted full approval to PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The decision makes PAPZIMEOS the first and on...
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Aug 12, 2025
Teva’s AJOVY Expanded by FDA as First Anti-CGRP Preventive for Pediatric Episodic Migraine; NRx Pharma’s NRX-100 Granted FDA Fast Track for Suicidal Ideation in Depression/Bipolar Depression; Boehringer Ingelheim’s HERNEXEOS Wins FDA Accelerated Approval for HER2-Mutant Advanced NSCLC; Genmab’s Phase III EPCORE FL-1 Meets Dual Endpoints in Relapsed/Refractory Follicular Lymphoma; Tiziana’s Phase II IND Cleared by FDA for Multiple System Atrophy
FDA Expands Teva’s AJOVY As First Anti-CGRP Preventive For Pediatric Episodic Migraine Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the FDA has approved AJOVY (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescents aged 6–...
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