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 Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria

July 20 2018

London UK; Philadelphia US; Geneva, Switzerland - July 20, 2018 -- GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel...

FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen

July 20 2018

July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference...

FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

July 20 2018

July 20, 2018 -- The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first...

FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

July 17 2018

TITUSVILLE, N.J, JULY 17, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide -...

FDA Approves TPOXX (tecovirimat) as the First Drug for the Treatment of Smallpox

July 13 2018

July 13, 2018 -- The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal...

FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

July 13 2018

TOKYO and NEW YORK, July 13, 2018 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental...