Merck’s KEYTRUDA QLEX Approved in Japan for Subcutaneous Use Across KEYTRUDA Indications Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved KEYTRUDA QLEX™ (pembrolizumab and…
Roche’s Ocrevus Gains Positive CHMP Opinion for Pediatric Multiple Sclerosis in Europe Roche (SIX: RO, ROP; OTCQX: RHHBY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the…
LEO Pharma Gains FDA Priority Review for Dersimelagon NDA Following Acquisition of Global Rights LEO Pharma, a global leader in medical dermatology, has announced two significant developments for dersimelagon, an investigational oral therapy being developed for the rare genetic skin…
Faeth Therapeutics Appoints Cancer Biology Expert Karen Vousden, Ph.D., to Board of Directors Faeth Therapeutics, Inc. (Nasdaq: FTH), a clinical-stage biotechnology company developing therapies designed to improve outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways, has announced…
Vyriad Receives FDA Clearance to Begin Phase 1 Trial of VV169 In Vivo CAR T Therapy for Multiple Myeloma Vyriad, Inc., a clinical-stage biotechnology company developing targeted genetic therapies for cancer and other serious diseases, announced that the U.S. Food…
SonoThera Appoints Adam J. Shaywitz, M.D., Ph.D., as Chief Medical Officer to Advance Genetic Medicine Pipeline SonoThera, a biotechnology company developing next-generation genetic medicines designed to address the underlying causes of disease, has appointed Adam J. Shaywitz, M.D., Ph.D., as…
Quanterix Appoints Dr. Yuri Fesko as Chief Medical Officer to Advance Diagnostics Strategy Quanterix Corporation, a global leader in precision biomarker science, has announced the appointment of physician executive Dr. Yuri Fesko as its new Chief Medical Officer. The appointment…
Scholar Rock Wins FDA Approval for ISEMBYLD, First Muscle-Targeted Treatment for Spinal Muscular Atrophy Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company focused on developing therapies for rare, severe and debilitating neuromuscular diseases through its expertise in myostatin biology, announced…
Bausch + Lomb Receives European CE Mark for Next-Generation SeeLyra Femtosecond Laser Bausch + Lomb Corporation (NYSE/TSX: BLCO), a global eye health company focused on helping people see better and live better, has announced that its next-generation SeeLyra femtosecond laser…
Nutromics Receives FDA Breakthrough Device Designation for Wearable Vancomycin Monitoring Patch Nutromics, a medical technology company developing a wearable lab-on-a-patch™ platform for continuous molecular monitoring, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD)…
Mirum Pharmaceuticals Appoints Rob Myers, M.D. as Chief Medical Officer to Lead Global Medical and Clinical Development Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a rare disease-focused pharmaceutical company developing medicines for patients with serious and often underserved conditions, has announced the…
Prilenia Therapeutics Appoints Neurology Expert Rick Munschauer as Chief Medical Officer Prilenia Therapeutics B.V., a biopharmaceutical company focused on developing potential treatments for neurodegenerative diseases, has announced the appointment of Frederick (Rick) E. Munschauer III, MD, MSc, FAAN, as its…