Category Regulatory

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)…

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…

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…