Bayer’s Lynkuet Receives FDA Priority Review for Vasomotor Symptoms Associated With Breast Cancer Endocrine Therapy Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Lynkuet® (elinzanetant) and granted the…
Alume Biosciences Receives FDA Breakthrough Therapy Designation for Bevonescein in Intraoperative Nerve Visualization Alume Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to bevonescein, an investigational fluorescent imaging agent being developed…
FDA Approves WELIREG Plus LENVIMA for Previously Treated Advanced Clear Cell Renal Cell Carcinoma Merck, known as MSD outside the United States and Canada, and Eisai announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan) in…
New Paper Provides Roadmap for Using Real-World Data in FDA Drug Approvals and Label Expansions Slipstream, a technology consulting partner focused exclusively on the life sciences industry, has announced the publication of a new peer-reviewed paper addressing how pharmaceutical and…
ImmunoScape Appoints Peter Olagunju as CEO to Advance TCR-Based Cancer Immunotherapy Platform Toward the Clinic ImmunoScape Pte. Ltd., an A*STAR spin-out backed by Amgen Ventures and EDBI, has appointed Peter Olagunju as its new Chief Executive Officer as the biotechnology…
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…