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- Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancerThe U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
- FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy reviewThe FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…