The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

Sarepta Therapeutics' Elevidys for DMD shows revenue potential, with market cap justified at $11.4bn and potential for >50% ...

By providing clearer nutrition information, the FDA hopes to empower consumers to make more informed food choices and contribute to long-term healthier eating patterns across the US.

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 ...

J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference.

The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T ...

The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...

Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...

Mizuho Securities analyst Uy Ear has assigned their bullish stance on SRPT stock, giving a Buy rating yesterday.Stay Ahead of the ...

Leerink Partners analyst Joseph Schwartz has reiterated their bullish stance on SRPT stock, giving a Buy rating yesterday.Stay Ahead of the ...