New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma

January 23 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 23, 2020-- Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of...

FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)

January 21 2020

DUBLIN--(BUSINESS WIRE)--Jan. 21, 2020-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). Tepezza is the...

FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease

January 16 2020

PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse...

FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia

January 13 2020

PHILADELPHIA, Jan. 13, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory...

FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment

January 13 2020

SAN DIEGO, CA – January 13, 2020 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent...

FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

January 08 2020

CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug...