FDA Seeks 10% Increase In Biden’s FY 2024 Budget, Proposes Enhancing Regulatory Authorities
The FDA has requested $7.2 billion as part of the president’s fiscal year 2024 budget, $128.2 million of which the…
FDA Casts Doubts Over Roche’s Polivy Label Expansion For Untreated Lymphoma Setting
Today, the FDA Oncologic Drugs Advisory Committee is discussing the supplemental marketing application for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab)…
The FDA has Cleared Vertex Pharmaceuticals’ Investigational New Drug Application For VX-264, Stem Cell-Derived Fully Differentiated Pancreatic Islet Cell Therapy Encapsulated Into Vertex-Developed, Immunoprotective Device For Type 1 Diabetes
Vertex plans to initiate a Phase 1/2 clinical trial in the first half of 2023 to study the safety, tolerability and efficacy of VX-264 in patients with T1D. The company previously received approval from Health Canada
Reported Late Wednesday March 08, Bionomics Reports Promising Full Results Analysis From PREVAIL Phase 2 Study Of BNC210 Social Anxiety Disorder; PREVAIL Did Not Meet Its Primary Endpoint
Both doses of BNC210 as an acute treatment resulted in reductions in anxiety across multiple phases of the public speaking challenge
Results achieved statistical significance in post-hoc analysis of the full
FDA Removes Regulatory Overhang From Inhibikase Therapeutics Parkinson, Atrophy Program
The FDA lifted the full Clinical Hold on Inhibikase Therapeutics Inc’s (NASDAQ:IKT) IkT-148009, the company’s c-Abl inhibitor, in Multiple System…
Enanta Pharmaceuticals To Present New Data For EDP-235, Its 3CL Protease Inhibitor, In Development As An Oral, Once-Daily Treatment For COVID-19, At The 36th International Conference On Antiviral Research
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that data for EDP-235, its lead 3CL protease
Mesoblast’s Lead Drug Candidate Goes Under FDA Priority Review For Bone Marrow Transplant Complications In Kids
Mesoblast Ltd (NASDAQ:MESO) rallied after the FDA agreed to review the company’s lead drug candidate, remestemcel-L, on a priority basis, more…
Sage Therapeutics & Biogen Reveal FDA Does Not Currently Plan To Convene Advisory Committee Meeting To Discuss NDA For Zuranolone In Treatment Of Major Depressive Disorder & Postpartum Depression
Sage Therapeutics, and Biogen announced that the U.S. Food and Drug Administration (FDA) notified the companies that the agency does not currently plan to convene an advisory committee meeting to discuss the
Covis Pharma To Withdraw Only FDA-Approved Treatment To Prevent Preterm Births
Privately held-Covis Pharma, the maker of Makena (hydroxyprogesterone caproate injection) to reduce the risk of preterm birth, said…