Margetuximab was approved by the US Food and Drug Administration (FDA) on December 16, 2020, for the treatment of metastatic HER2-positive breast cancer in combination with chemotherapy.

Jul 9th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

Tirbanibulin, marketed under the brand name Klisyri, is a topical ointment used primarily to treat actinic keratosis.

Johnson & Johnson revealed that the U.S. Food and Drug Administration has granted conventional approval for SIRTURO (bedaquiline).

Berotralstat received approval from the US Food and Drug Administration (FDA) on December 3, 2020.

Sobi submits biologics license application to the FDA for SEL-212, targeting chronic refractory gout treatment.

Setmelanotide received FDA approval on November 25, 2020. The approval was granted for the treatment of obesity caused by rare genetic disorders.

Tyra Biosciences has reported preclinical proof-of-concept findings for TYRA-300, an experimental orally administered FGFR3 selective inhibitor.

Naxitamab received accelerated approval from the U.S. Food and Drug Administration (FDA) on November 25, 2020.

Satellos Reveals Initial Data Indicating Muscle Recovery and Healing from SAT-3247 Treatment in Dog Model of Duchenne Muscular Dystrophy (DMD).

Casirivimab and Imdevimab received Emergency Use Authorization (EUA) from the FDA on November 21, 2020.

The U.S. FDA has granted approval for Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), developed by Eli Lilly and Company.