A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

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.

Viking Therapeutics announced the start of Phase 3 studies involving its injectable, GLP-1/GIP-targeted obesity drug, called ...

Early last year, Biogen pulled the plug on the treatment. Biogen FDA Office of Inspector General (OIG) Department of Health and Human Services (HHS) accelerated approval Sarepta Makena Exondys 51 ...

Biogen’s Aduhelm, Sarepta’s Exondys 51, along with Covis Pharma’s Makena were all cleared quickly by the US Food and Drug Administration despite weak evidence and disagreements among reviewers, ...

Sarepta's now in front of the FDA again, seeking accelerated approval for a gene therapy for muscular dystrophy. A decision is expected by the end of this month.

The FDA limited the approval of Sarepta Therapeutics’ treatment to patients ages 4 to 5 years old ... But it drew criticism in 2021 after the FDA cleared Biogen’s controversial Alzheimer ...

Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Sarepta Therapeutics (SRPT – Research Report), Crispr Therapeutics AG (CRSP – Research Report ...

Biogen Inc. is making good on its promise to focus on “external opportunities,” this time with a new deal involving a Bedford-based biotech. Boston Business Journal. Select a City ...

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.