pharma news
Aug 08, 2023
FDA Approves ZURZUVAE for Postpartum Depression; Astellas Drug Acquired in $5.9B Deal Wins FDA Approval; FDA Clearance to Phase III Study of Lisaftoclax; FDA Issues CRL to BLA Resubmission for Remestemcel-L; Bavarian Nordic Updated on its Chikungunya Virus Vaccine; FDA Orphan Drug Designation to ABM-1310
FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily t...
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Aug 01, 2023
FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa
FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...
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Jul 18, 2023
Lilly to Acquire Versanis; FDA Approves Beyfortus for RSV in Infants; Alnylam Presented Updates on Interim Phase 1 Results for ALN-APP; FDA Accepts NDA for Rivoceranib Plus Camrelizumab; FDA Fast Track Designation to Karyopharm’s Selinexor; Adcentrx’s IND Application for ADRX-0706
Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases Eli Lilly & Company and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical firm focused on the discovery of novel medications for the treatment of cardiometab...
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Jul 11, 2023
FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD
Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...
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Jul 04, 2023
First Gene Therapy for Severe Hemophilia A; FDA Approves CellTrans’s Type 1 Diabetes Cellular Therapy; FDA Approve Amneal’s Parkinson’s Drug Over Safety Concerns; NLS Pharmaceutics’s Phase III Clinical Trials of Quilience; Genenta Science’s Temferon for the Treatment of Glioma; FDA Fast Track Designation to GSK’s Gonorrhea Drug
FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...
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Jun 27, 2023
FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma
FDA Approves Jardiance for the Treatment of Type 2 Diabetes in Children 10 Years and Older Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years and older w...
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Jun 20, 2023
FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap
GSK Announces Extension of FDA Review Period for Momelotinib After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug'...
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Jun 13, 2023
FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result
FDA Grants Fast Track Status to KYV-101 for Refractory Lupus Nephritis Treatment Kyverna Therapeutics announced that the FDA has given Fast Track status to KYV-101, a treatment for patients suffering from resistant lupus nephritis (LN). KYV-101 is an innovative therapy that uses anti-CD19 chimeric antigen recept...
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Jun 06, 2023
Daiichi Sankyo’s Intravenous Iron Replacement Therapy; ANeuroTech’s Adjunctive Anti-depression Drug, ANT-01; Kyverna Therapeutics’s KYV-101 in Lupus Nephritis; Servier Presents Data from Phase 3 INDIGO Trial of Vorasidenib; FDA Approves Pfizer’s ABRYSVO
FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults Pfizer Inc. announced that the FDA has authorized ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory...
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May 30, 2023
FDA Approves Lexicon’s INPEFA (Sotagliflozin); PTC Therapeutics’s Vatiquinone MOVE-FA Registration-Directed Trial; EU Approval to Novartis’s Sickle Cell Disease Drug; EMA Approves Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC; FDA Grants Priority Review to Fruquintinib for mCRC; FDA Orphan Drug Designation to Vega Therapeutics’s VGA039
Lexicon Announces FDA Approval of INPEFA (Sotagliflozin) For Treatment of Heart Failure Lexicon Pharmaceuticals, Inc. announced that the FDA has approved INPEFATM (sotagliflozin), a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure vis...
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