Category Regulatory

FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S. Food and Drug Administration’s (FDA) accelerated approval of Lynozyfic™ (linvoseltamab-gcpt), a first-in-class…

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. and Canada, has announced a significant regulatory milestone for…

Jazz Pharmaceuticals Secures Conditional EU Approval for Ziihera® (zanidatamab) to Treat Advanced HER2-Positive Biliary Tract Cancer Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has announced that the European Commission (EC) has granted conditional marketing authorization for Ziihera® (zanidatamab), a dual HER2-targeted bispecific…

Takeda Secures FDA Approval for GAMMAGARD LIQUID ERC, the First Ready-to-Use Liquid Immunoglobulin Therapy with Low IgA Content Takeda (TSE:4502/NYSE:TAK) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for GAMMAGARD LIQUID ERC [immune globulin infusion…

Vertex Gains EU Approval for ALYFTREK®, a Next-Generation CFTR Modulator for Cystic Fibrosis Patients Vertex Pharmaceuticals (Nasdaq: VRTX) announced today that the European Commission has granted marketing authorization for ALYFTREK® (deutivacaftor/tezacaftor/vanzacaftor), a new, once-daily triple-combination CFTR modulator therapy for the…

FDA Accepts Allergan’s Application to Expand SKINVIVE by JUVÉDERM® for Neck Line Treatment Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental premarket approval (sPMA) application for SKINVIVE by…

Global pharmaceutical major Lupin Limited announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. These tablets are the generic…

Teva and Alvotech Expand U.S. Biosimilar Portfolio with Approval for SELARSDI™ Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) have announced that the U.S. Food and Drug Administration (FDA) has…

Genmab to Submit sBLA to FDA for Epcoritamab Combo in Relapsed/Refractory Follicular Lymphoma Genmab A/S, a leading international biotechnology company specializing in the development of antibody therapeutics for the treatment of cancer and other serious diseases, announced today its intention…

Xencor Reports Positive Early Data for Anti-TL1A Antibody in Bowel Disease Xencor, Inc. a leading clinical-stage biopharmaceutical company specializing in the development of engineered antibodies for the treatment of cancer and autoimmune diseases, has announced positive interim results from the…

Alnylam Secures Positive CHMP Recommendation for Vutrisiran in Treating ATTR Amyloidosis with Cardiomyopathy In a significant regulatory milestone for RNA interference (RNAi) therapeutics, Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the industry leader in RNAi-based drug development, has announced that the Committee…