FDA Issues Complete Response Letter to Aldeyra for Reproxalap Dry Eye NDA Aldeyra Therapeutics, Inc.a biotechnology company committed to the development of innovative therapies targeting immune-mediated and metabolic diseases, announced today that it has received a Complete Response Letter (CRL)…
Revvity, Inc. (NYSE: RVTY) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Auto-Pure 2400 liquid handling platform in combination with the T-SPOT.TB test. This approval represents a significant breakthrough in the field of…
Sydnexis Receives Positive CHMP Opinion for SYD-101 in Europe to Slow Pediatric Myopia Progression Sydnexis, Inc. a pre-commercial stage biopharmaceutical company specializing in ophthalmic therapeutics, has announced a significant regulatory milestone. The European Medicines Agency’s (EMA) Committee for Medicinal Products…
Sanofi and Alnylam Secure Landmark RNAi Approval for Hemophilia A & B Sanofi and Alnylam have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval to fitusiran, their RNA interference (RNAi) therapy, for the treatment…
European Commission Approves TIVDAK® for Recurrent or Metastatic Cervical Cancer Genmab A/S has announced that the European Commission (EC) has officially granted marketing authorization for TIVDAK® (tisotumab vedotin), an antibody-drug conjugate (ADC), as a monotherapy treatment for adult patients diagnosed…
Vertex Pharmaceuticals Secures UK MHRA Approval for ALYFTREK®, a Next-Generation CFTR Modulator for Cystic Fibrosis Vertex Pharmaceuticals announced today that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for ALYFTREK® (deutivacaftor/tezacaftor/vanzacaftor), a next-in-class, once-daily…
Japan Approves TIVDAK® for Advanced Cervical Cancer Treatment Genmab A/S has announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved TIVDAK® (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed following…
Health Canada Approves 4Moving Biotech’s Phase 2a Trial for Knee Osteoarthritis 4Moving Biotech (4MB), a spin-off of 4P-Pharma dedicated to developing first-in-class treatments that modify the natural history of knee osteoarthritis, has received authorization from Health Canada to initiate the…
FDA Approves CABOMETYX® (Cabozantinib) for Advanced Neuroendocrine Tumors, Expanding Treatment Options Exelixis, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the treatment of adult and pediatric patients aged 12 years and older…
Coya Therapeutics Advances Treg-Derived Exosome Program Coya Therapeutics, Inc. (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function, has provided a comprehensive update on its investigational regulatory T cell-derived exosome…
FDA Approves Blujepa (Gepotidacin) for uUTIs in Adults & Teens GSK plc has announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults (weighing ≥40…
Novartis’ Fabhalta® (iptacopan) Wins Third FDA Approval for C3G Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved oral Fabhalta® (iptacopan) for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria. This milestone makes…