Category Regulatory

Moderna Secures Full FDA Approval for Spikevax in High-Risk Children Amid Growing mRNA Scrutiny Moderna has scored another key regulatory milestone as the U.S. Food and Drug Administration (FDA) granted full approval for the company’s COVID-19 vaccine, Spikevax, for use…

FDA Approves Merck Animal Health’s BRAVECTO® QUANTUM, a Year-Long Injectable Flea and Tick Treatment for Dogs Merck Animal Health, a division of Merck & Co., announced FDA approval of BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension)—a once-yearly injectable treatment for…

Merck’s NDA for Once-Daily Doravirine/Islatravir HIV Regimen Accepted by U.S. FDA Merck, known as MSD outside the U.S. and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an…

FDA Accepts sNDA for INQOVI® Plus Venetoclax for Newly Diagnosed AML Patients Ineligible for Intensive ChemotherapyCombination therapy met primary efficacy endpoint with no new safety signals; would represent the first all-oral regimen for this patient population if approved Taiho Pharmaceutical…

FDA Approves Label Update for Lilly’s Alzheimer’s Drug Kisunla in Bid to Enhance Safety and Broaden Use The U.S. Food and Drug Administration (FDA) has approved a significant label update for Eli Lilly’s Alzheimer’s drug Kisunla, aimed at addressing persistent…

FDA Greenlights Label Update and Revised Dosing Schedule for Lilly’s Kisunla (donanemab‑azbt) in Early Symptomatic Alzheimer’s Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved an updated product label for Kisunla® (donanemab-azbt). This…

InnoCare Secures IND Approval in China for B7-H3-Targeted ADC ICP-B794 to Advance Solid Tumor Therapies InnoCare Pharma a leading biopharmaceutical company dedicated to developing innovative treatments for cancer and autoimmune diseases, announced the recent approval of its Investigational New Drug…

Biotech Executives and Investors Urge FDA to Preserve Access to Mifepristone Amid Legal Uncertainty A group of leading biotechnology executives, investors, and scientific experts are urging the U.S. Food and Drug Administration (FDA) to safeguard continued access to mifepristone, a…

Regeneron Secures FDA Accelerated Approval for Lynozyfic in Multiple Myeloma, Eyes Differentiation Despite Market Head Start by Rivals In a bid to strengthen its oncology portfolio, Regeneron Pharmaceuticals announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted…

Regeneron’s Lynozyfic™ Secures FDA Accelerated Approval for Heavily Pretreated Multiple Myeloma Patients Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with…

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…