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…
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…
