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 Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children

June 22 2022

Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four-dose series and superior immune responses for important disease-causing shared serotype 3 and unique serotypes 22F...

Skyrizi (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults

June 16 2022

Third approved indication for Skyrizi (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating Skyrizi in moderately to severely active Crohn's disease, ADVANCE, MOTIVATE and...

Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Use in Patients with Bardet-Biedl Syndrome

June 16 2022

Imcivree now available for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome First and only FDA-approved therapy that targets impairment in the MC4R...

FDA Approves Lilly and Incyte's Olumiant (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areata

June 12 2022

INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib), a once-daily pill, as a first-in-disease...

FDA Approves Amvuttra (vutrisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

June 12 2022

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 13, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) approved Amvuttra (vutrisiran), an RNAi...

FDA Approves Expansion of CellCept (mycophenolate mofetil) Indication to Pediatric Heart Transplant and Pediatric Liver Transplant Populations

June 08 2022

June 8, 2022 -- FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in pediatric recipients of allogenic heart and allogeneic liver transplants aged 3 months and older in combination with other...