The U.S. Food and Drug Administration on Friday extended for the second time its review of Amicus Therapeutics Inc.’s experimental combination therapy to treat a muscle disorder called Pompe disease.
Tag Archive for: U.S. Food and Drug Administration (FDA)
Gilead’s hopes for an approval in hepatitis delta virus (HDV) infection and compensated liver disease will have to wait following an FDA rejection.
An FDA adcomm that met Wednesday to vote on GlaxoSmithKline’s daprodustat for adult patients with anemia due to chronic kidney disease (CKD) produced mixed results.
The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co. Plc’s over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday.
The FDA greenlit AstraZeneca’s anti-CTLA-4 antibody tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while simultaneously examining several endpoints.
A Phase II trial studying PTC Therapeutics’ PTC518 in Huntington’s disease (HD) has been paused in the United States following a request from the FDA for additional data, the company announced Tuesday afternoon.
The U.S. Food and Drug Administration has extended the review of Biogen Inc.’s (BIIB.O) experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) by three months, the company said on Monday.
Major U.S. retailers will begin selling lower-cost hearing aids without a prescription or medical exam under final Biden administration rules that take effect Monday.
The U.S. Food and Drug Administration said on Wednesday there was a shortage of Adderall, a treatment for attention deficit hyperactivity disorder, following intermittent manufacturing delays at Teva Pharmaceutical Industries Ltd.
