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 Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP)

August 19 2019

DUBLIN, Ireland, Aug. 19, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today...

FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis

August 16 2019

NORTH CHICAGO, Ill., Aug. 16, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), a 15 mg, once-daily oral...

FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis

August 16 2019

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or...

FDA Approves Wakix (pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy

August 15 2019

PLYMOUTH MEETING, PA, August 15, 2019 — Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients...

FDA Approves Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

August 15 2019

South San Francisco, CA -- August 15, 2019 -- 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 Rozlytrek (entrectinib) for the treatment of adults with...

FDA Approves Pretomanid for Highly Drug-Resistant Forms of Tuberculosis

August 14 2019

NEW YORK August 14, 2019 - Pretomanid, a novel compound developed by the non-profit organization TB Alliance, was approved by the U.S. Food & Drug Administration (FDA) today for treating some of the most drug-resistant forms of tuberculosis...