The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of ...
In the CodeBreaK 300 trial, sotorasib and panitumumab had better response rates and improved PFS vs standard-of-care ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of ...
After reviewing the scientific evidence, the agency has decided 20 ZYN nicotine pouch products can legally be sold in the US.
A drug from AstraZeneca and Daiichi Sankyo won authorization for a form of breast cancer, the first U.S. approval for the ...
The US Food and Drug Administration approved 50 new molecular entities in 2024 —just five fewer than it did in 2023. Last ...
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients ...
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...