A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...

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 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 ...

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 ...

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

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 ...

Sarepta (SRPT) Therapeutics announced that enrollment and dosing is complete in EMERGENE or Study SRP-9003-301 , a Phase 3 clinical trial of SRP-9003 or bidridistrogene xeboparvovec . SRP-9003 is ...

Sarepta Therapeutics (SRPT – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst on December 18. Analyst Mitchell Kapoor from H.C. Wainwright reiterated a ...

The properties include the headquarters for Sarepta Therapeutics and Editas Medicine. Blackstone and its affiliate, BioMed Realty, have paid $250 million to Alexandra Real Estate Equities Inc. to ...