FDA Updates Week of March 28, 2022
April 2nd 2022The FDA authorizes second COVID-19 booster and approves a higher does of Ozempic, Cabenuva for adolescents with HIV, a therapy for rare seizer disorder, and an oral testosterone replacement. The agency issues a complete response letter for a therapy for anemia related to chronic kidney disease, and an advisor committee votes down a drug for ALS.
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FDA Updates for Week of March 14, 2022
March 19th 2022FDA approves first generic of Symbicort for asthma and COPD and first therapy for rare seizure disorder, Rinvoq and Lynparza get nods for new indications, the agency approves a new delivery system for Alzheimer’s therapy, regulators extend review for Opzelura for skin condition and issue CRL for Fasenra for chronic rhinosinusitis.
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Cabometyx Combo Doesn’t Meet Survival Endpoint in Advanced Liver Cancer Trial
March 15th 2022After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.
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