New Drug Approvals

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

U.S. FDA Approves Over-the-Counter Designation for Emergent BioSolutions’ Narcan Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment

March 29 2023

GAITHERSBURG, Md., March 29, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved Narcan® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC)...

FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

March 26 2023

LEIDEN, The Netherlands, March 24, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Drug Administration (FDA) has approved Joenja (leniolisib) for the...

FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis

March 22 2023

SAN DIEGO & PARSIPPANY, N.J.--(BUSINESS WIRE)-- March 22, 2023 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved Rezzayo (rezafungin for injection)...

FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)

March 22 2023

WILMINGTON, Del.--(BUSINESS WIRE)--Mar. 22, 2023-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1...

FDA Approves First-in-class Evkeeza (evinacumab-dgnb) for Young Children with Ultra-Rare Form of High Cholesterol

March 22 2023

TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other...

Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation

March 21 2023

Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will offer US patients reduced injection volume...