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August 09, 2022
The approval had been delayed as the regulatory agency reviewed data on Myfembree's impact on bone mineral density.
August 08, 2022
Confirmed cases of monkeypox in the United States have reached more than 7,500, according to the CDC.
Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.
August 06, 2022
The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.
August 05, 2022
This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.
The committee will meet on Sept. 7, 2022, to discuss additional analyses of data from the Amylyx’s clinical studies. The updated PDUFA goal date is Sept. 29, 2022.
The FDA has requested Acadia conduct an additional trial of Nuplazid to support an indication in patients with Alzheimer’s disease.
August 04, 2022
Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval in both intravenous and subcutaneous administration.
Results indicated the trial is unlikely to meet its primary endpoint, the change from baseline in the six-minute walk test at 24 weeks.
This is the second trial in less than a month studying Keytruda that failed to meet endpoints.
