Regulatory Affairs

      Alnylam Stock Trading Halted Today; FDA Advisory Committee to Review Supplemental New Drug Application for Patisiran for the Treatment of the Cardiomyopathy of ATTR...

      CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that NASDAQ has halted trading of the Company’s common stock. The U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee is meeting today to review the supplemental New Drug Application for patisiran, an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) a

      Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

      OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of ENTYVIO® (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with ENTYVIO intravenous (IV). An application for the SC administration of ENTYVIO for the treat

      MaaT Pharma Announces European Medicines Agency Granted MaaT033 Orphan Drug Designation aiming to improve overall survival in patients undergoing Hematopoietic Stem Cell transplantation

      LYON, France--(BUSINESS WIRE)---- $MAAT--Regulatory News: MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, announced that the European Medicines Agency (EMA) has granted MaaT033 orphan drug designation aiming to improve overall survival in patients undergoing HSCT and has recognized the significant benefit that MaaT033 could there

      Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19

      SAN DIEGO--(BUSINESS WIRE)---- $ARCT #ClinicalTrial--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, and CSL (ASX:CSL), and its vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, announced today that the European Medicines Agency (EMA) has validated the marketing authori

      IND for ATA-100, a Gene Therapy for the Treatment of Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9), cleared to proceed by FDA

      EVRY, France--(BUSINESS WIRE)--“This IND clearance in an important step to bring ATA-100 to US patients suffering from this highly debilitating LGMD-R9 disease.”

       Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate

      BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. Lisdexamfetamine dimesylate capsules is a generic version of Vyvanse®. This ADHD product is currently on the U.S. FDA shortage product list, and Amneal has already begun sup

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