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 Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

November 27 2020

BOSTON, Nov. 27, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S....

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

November 27 2020

NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel,...

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

November 24 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 24, 2020-- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for...

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person

November 22 2020

South San Francisco, CA -- November 23, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for...

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

November 20 2020

PALO ALTO, Calif., Nov. 20, 2020 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and...

Imfinzi Approved in the US for Less-Frequent, Fixed-Dose Use

November 19 2020

20 November 2020 -- AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer...