The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.

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

The positive results from the second part of the EMBARK trial contrast with findings from one-year post treatment, which did ...

One expert contrasted Biogen’s filing with the flimsy data the FDA controversially accepted last year to approve Sarepta’s Exondys 51 (eteplirsen) for Duchenne muscular dystrophy, another rare ...

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

Sarepta Therapeutics, Inc., a commercial-stage biopharmaceutical company, focuses on the discovery and development of RNA-targeted therapeutics, gene therapies, and other genetic therapeutic ...

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 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 ...

In a report released today, Uy Ear from Mizuho Securities maintained a Hold rating on SAGE Therapeutics (SAGE – Research Report), with a price ...

Analyst Mitchell Kapoor from H.C. Wainwright reiterated a Sell rating on Sarepta Therapeutics (SRPT – Research Report) and keeping the price target at $75.00. Discover outperforming stocks and ...