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 Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine

September 02 2021

SEATTLE, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Impel NeuroPharma, Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial...

FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia

September 01 2021

TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone...

U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenström’s Macroglobulinemia

August 31 2021

CAMBRIDGE, Mass. & BEIJING, September 01, 2021--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that Brukinsa...

UCB Announces Briviact (brivaracetam) Now FDA-Approved to Treat Partial-Onset Seizures in Pediatric Patients One Month of Age and Older

August 30 2021

ATLANTA, Aug. 30, 2021 /PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in...

Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma

August 25 2021

Tibsovo is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma BOSTON, Aug. 25, 2021 /PRNewswire/ -- Servier Pharmaceuticals, a growing leader in oncology committed to bringing the...

FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency

August 24 2021

COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in...