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 Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer

May 24 2019

May 24, 2019 -- Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor...

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters

May 20 2019

Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) Nayzilam...

FDA Approves Gattex (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)

May 17 2019

Lexington, MA, May 17, 2019 – Takeda Pharmaceuticals, U.S.A., Inc. (“Takeda”), announced today that the U.S. Food and Drug Administration (FDA) approved extending the indication of Gattex (teduglutide) for injection to pediatric...

FDA Approves Fragmin (dalteparin sodium) as First Anticoagulant for Venous Thromboembolism in Pediatric Patients

May 16 2019

May 16, 2019 -- The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older....

AbbVie Announces US FDA Approval of Venclexta (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients

May 15 2019

NORTH CHICAGO, Ill., May 15, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with...

FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

May 14 2019

RALEIGH, N.C. – May 13, 2019 – Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin...