FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for…
Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder (NMOSD) Ultomiris (ravulizumab) has been approved in the European Union (EU) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4)…
REGENERON AND ALNYLAM REPORT POSITIVE INTERIM PHASE 1 CLINICAL DATA ON ALN-APP, AN INVESTIGATIONAL RNAI THERAPEUTIC FOR ALZHEIMER’S DISEASE AND CEREBRAL AMYLOID ANGIOPATHY Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today positive interim results from the ongoing single ascending dose…
Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection.…
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the…
FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced…
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with neuromyelitis…
Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed Relapsed and/or Refractory Multiple Myeloma U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target…
FDA approves Roche’s Policy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Polivy® (polatuzumab…
U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative…
Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications AbbVie (NYSE: ABBV) announced today the intent to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell…