Last fall, the Food and Drug Administration (FDA) recommended discontinuing the use of oral phenylephrine in over-the-counter (OTC) cold and cough products due to concerns over its effectiveness. This decision has raised questions about which phenylephrine products are affected and…
Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company fully owned and operated as a subsidiary of Bayer AG, announced that its investigational gene therapy, AB-1003 (also known as LION-101), has been granted both Rare Pediatric Disease and Orphan Drug designations…
The Access and Allocation Mechanism (AAM) for mpox has allocated an initial 899,000 vaccine doses to nine African countries severely impacted by the ongoing mpox outbreak. This distribution, made in collaboration with affected nations and donors, aims to ensure effective…
Libra Therapeutics, Inc., a private biotechnology company focused on developing innovative therapies to restore cellular balance and reduce neurodegeneration, has announced the appointment of Shawn A. Scranton, PharmD, as President and Chief Executive Officer. Dr. Scranton brings 30 years of…
Exelixis, Inc. (Nasdaq: EXEL) released its third-quarter financial results for 2024 and highlighted recent progress across key commercial, clinical, and pipeline milestones. Key Developments and Corporate Updates Pipeline and Clinical Trials Cabozantinib Franchise Revenue: The cabozantinib franchise generated $478.1 million…
Dr. Reddy’s Laboratories Ltd. has been recognized as one of the top employers in the 2024 Top Biotech and Pharma Employers Survey conducted by Science magazine, marking the company’s third consecutive year on the prestigious list. In the 2022 survey,…
Maze Therapeutics, a clinical-stage biopharmaceutical company focused on leveraging human genetics to create innovative small molecule precision medicines for common diseases, has announced promising results from the Phase 1 clinical trial of its drug candidate MZE829 in healthy volunteers. MZE829…
Evecxia Therapeutics has announced the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) Division of Psychiatry, Office of Neuroscience, Center for Drug Evaluation and Research. This meeting is pivotal for the…
Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals,…
GSK’s Gepotidacin Accepted for FDA Priority Review to Treat Uncomplicated UTIs GSK plc (LSE/NYSE: GSK) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for gepotidacin, a first-in-class oral antibiotic with a…
PDUFA Goal Date Set for June 13, 2025: UGN-102 Could Be First FDA-Approved Treatment for LG-IR-NMIBC UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company committed to developing innovative solutions for urothelial and specialty cancers, has announced that the U.S. Food…
Heidelberg Engineering, a leading provider of ophthalmic imaging and healthcare data solutions, has announced that the FDA has granted clearance for its SPECTRALIS® Flex Module. This advanced, multimodal imaging platform is specifically designed to perform diagnostic imaging of the posterior…
