Reported Late Monday March 13, Everest Medicines Announces Partner Calliditas Therapeutics Reports Topline Results From Phase 3 NefIgArd Trial Evaluating Nefecon In IgA Nephropathy; Trial Primary Endpoint Was Met With Nefecon
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that its partner Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX)))) ("Calliditas") reported
Reported Late Monday March 13, Innoviva Announces FDA Advisory Committee Meeting To Review Sulbactam-Durlobactam An Investigational Targeted Antibiotic On April 17, 2023
Innoviva, Inc. (NASDAQ:INVA) ("Innoviva"), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration's (FDA)
Acadia Pharma’s Rett Syndrome Drug Becomes First FDA-Approved Treatment
The FDA has approved Acadia Pharmaceuticals Inc’s (NASDAQ:ACAD) Daybue (trofinetide) for Rett syndrome in adult and pediatric patients two years of…
Hefty Listing Price Of New Drugs For Cancer, Rare Diseases Put Pressure On Annual Hike For Older Drugs
New branded medicines are coming to market with ever-higher price tags as soon as the first day. Amgen Inc's (NASDAQ: AMGN) lung cancer treatment, Lumakras, carried a hefty price tag of $17,900 per patient monthly when it launched in 2021.
FDA Addresses ‘Misinformation’ Concerning Delayed Approval Of Lucira Health’s COVID-19 & Flu Home Test
The FDA provided additional information about the agency’s interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health Inc’s (OTC: LHDXQ)…
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