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…
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a global leader in eye health, has announced that the U.S. Food and Drug Administration has approved the enVista® Envy™ intraocular lens (IOL). This new lens offers a full range of vision with superior…
Biogen Inc. (Nasdaq: BIIB) – Biogen announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to felzartamab, an investigational anti-CD38 monoclonal antibody. This designation is for the treatment of late antibody-mediated rejection (AMR)…
Pfizer Inc. (NYSE: PFE) has announced that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis aimed at preventing or reducing bleeding episodes in adults and pediatric patients aged 12 and older with hemophilia A…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Itovebi™ (inavolisib) for use in combination with palbociclib (Ibrance®) and fulvestrant to treat adults with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor…
SSegal Trials is proud to have played a significant role in the FDA approval of COBENFY™ (xanomeline and trospium chloride), a pioneering first-in-class muscarinic agonist developed by Bristol Myers Squibb for treating schizophrenia in adults. This landmark approval represents a…
Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) for adult patients with resectable non-small cell lung cancer (NSCLC) characterized by tumors measuring 4 cm or larger or node-positive cases, provided…
Bristol Myers Squibb (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) whose tumors are ≥4 cm or node-positive and…
Fresenius Kabi, a subsidiary of Fresenius specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, along with Formycon AG, a leading developer of high-quality biosimilars, announced the approval of Otulfi™ (ustekinumab-aauz) by the…
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a clinical-stage biotherapeutics company committed to improving the lives of patients with serious diseases, announced today that KarXT (a combination of xanomeline and trospium chloride), initially developed by PureTech, has received FDA approval…