New Drug Approvals

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

Enhertu Approved in the US as the First HER2-Directed Therapy for Patients with HER2-Low Metastatic Breast Cancer

August 06 2022

Based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy 6 August 2022 --...

Calquence Tablet Formulation Approved in the US Across Current indications

August 05 2022

New formulation can be co-administered with gastric acid-reducing agents Tablet offers equivalent efficacy, safety and consistent dosing compared to current capsule 5 August 2022 -- AstraZeneca’s new tablet formulation of Calquence...

Myovant Sciences and Pfizer Receive U.S. FDA Approval of Myfembree, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

August 04 2022

BASEL, Switzerland and NEW YORK, [August 05, 2022] (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Myfembree® (relugolix 40 mg,...

FDA Approves Juvéderm Volux XC for Improvement of Jawline Definition

August 03 2022

IRVINE, Calif., Aug. 3, 2022 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of Juvéderm® Volux™ XC for the improvement of jawline definition in adults over the age of...

FDA Approves Cimerli (ranibizumab-eqrn), an Interchangeable Biosimilar to Lucentis

August 02 2022

REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cimerli (ranibizumab-eqrn) as a biosimilar...

FDA Approves Kyzatrex (testosterone undecanoate) for the Treatment of Male Hypogonadism

August 02 2022

RALEIGH, N.C., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of Kyzatrex (testosterone undecanoate) by the U.S. Food and Drug Administration (FDA). Kyzatrex is an oral...