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The Food and Drug Administration has approved an additional warning in labeling for Kybella (deoxycholic acid) injection regarding adverse reactions associated with use of the drug outside of the submental fat region (fat under the chin, known as a “double chin”) and recommends against this unapproved use. The agency approved this revised labeling after its …

FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use Read More »

The U.S. Food and Drug Administration toThe U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot. Currently, first-in-human clinical trials may take up to two years to complete in the United States. The same types of trials are completed much faster in China and Australia, threatening America’s …

FDA Launches Expedited IND Pilot, Begins Accepting Applications Read More »

The U.S. Food and Drug Administration today approved Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment. Isembyld is the first therapy approved for SMA that directly targets muscle loss, working alongside existing treatments to address a …

FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy Read More »

FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children 4-11 years who weigh at least 27 kg. Joenja was first approved in 2023 for the same indication in patients 12 years and older at a dose of 70 mg orally twice a day. Children 4-11 …

Notable Approval: FDA approves first treatment for children aged 4-11 years with APDS, a rare genetic disorder of the immune system Read More »

On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

The U.S. Food and Drug Administration issued a final administrative order removing two active ingredients — aminobenzoic acid (PABA) and trolamine salicylate — from the list of ingredients that can be used in sunscreen drug products under the OTC sunscreen monograph. FDA determined that the risks associated with use of these active ingredients in sunscreen …

FDA Issues Final Order Removing PABA and Trolamine Salicylate as Sunscreen Active Ingredients Read More »