FDA Grants Full Approval to Bayer’s VITRAKVI® (Larotrectinib), a Landmark TRK Inhibitor for Patients with NTRK Fusion-Positive Solid Tumors In a milestone for precision oncology, Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted full regulatory…
New Cancer Cell Study Backs CEL-SCI’s Early Approval Bid for Multikine in Head & Neck Cancer CEL-SCI Corporation (NYSE American: CVM), a clinical-stage immunotherapy company developing innovative treatments for cancer and infectious diseases, today announced findings that reinforce the scientific…
Agitated Solutions Gets FDA IND Nod for Phase 3 Contrast Agent Trial Agitated Solutions, Incorporated (ASI), a medical technology company focused on cardiovascular imaging innovation, announced a pivotal regulatory milestone this week: the U.S. Food and Drug Administration (FDA) has…
FDA Approves Opdivo Plus Yervoy® for Untreated MSI-H or dMMR Metastatic Colorectal Cancer Bristol Myers Squibb today announced a major milestone in cancer immunotherapy with the U.S. Food and Drug Administration (FDA) granting approval for the combination of Opdivo® (nivolumab)…
Avenacy Introduces Propofol Injectable Emulsion, USP to the U.S. Market Avenacy Launches FDA-Approved Propofol Injectable Emulsion, USP in the United States: A Milestone in Critical Care and Anesthesia Access Avenacy, a rising force in the specialty pharmaceutical sector, announced today…
EU Approves Expanded Use of KAFTRIO for Cystic Fibrosis Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has announced a significant milestone in the ongoing fight against cystic fibrosis (CF). The European Commission (EC) has officially approved a label expansion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor),…
Sentynl Unveils First Full Clinical Data Supporting NULIBRY® for MoCD Type A Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company and a wholly owned subsidiary of Zydus Lifesciences Ltd. (“Zydus Group”), has proudly announced the publication of pivotal clinical studies…
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…