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, ...

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

Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...

SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by ...

(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators ... around transparency. While FDA records showed 13 meetings between ...

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 ...

Atara stock plunges 41% upon the FDA issuance of a CRL against its BLA for Ebvallo to treat EBV+ PTLD. The company is also facing a severe cash crunch.

The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...