New Drug Approvals

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

Tremfya (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

July 14 2020

HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis...

FDA Approves Upneeq (oxymetazoline hydrochloride ophthalmic solution) for Acquired Blepharoptosis (Droopy Eyelid) in Adults

July 09 2020

BRIDGEWATER, N.J, July 09, 2020 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that the U.S. Food and Drug...

FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira

July 09 2020

HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA)...

Ipsen Announces Updated Indication for Dysport (abobotulinumtoxinA) for the Treatment of Spasticity in Children

July 08 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE) July 09, 2020 --Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport...

FDA Approves Expanded Botox (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity

July 08 2020

NORTH CHICAGO, Ill., July 9, 2020 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of...

FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML)

July 07 2020

Pleasanton, CA, Princeton, NJ, and Tokyo, Japan, July 7, 2020. Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved...