A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...

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

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

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

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 ...

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

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

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported preliminary* fourth quarter and full-year 2024 net product revenue and cash on hand ...

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 ...

Sarepta Therapeutics exceeded 2024 net product revenue guidance and reaffirmed its 2025 outlook, partly due to strong growth for Duchenne muscular dystrophy drug Elevidys. The company reported ...

Analysts at Goldman Sachs predict the Magnificent 7 stocks will continue to dominate, but the growth differential may narrow ...