The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

PORTLAND, IN, UNITED STATES, January 28, 2025 /EINPresswire / -- The RNA based therapeutics has been explored as a promising treatment option for the diseases which are difficult to treat. Development ...

For example, Sarepta has yet to complete its confirmatory ... The decision prompted three members of the panel to quit. Early last year, Biogen pulled the plug on the treatment.

Sarepta Therapeutics (NASDAQ:SRPT) has been analyzed by 14 analysts in the last three months, revealing a diverse range of perspectives from bullish to bearish. The table below provides a concise ...

The agency labeled the action a Class I recall, its most serious designation. (Dubinsky, 1/14) Bloomberg: Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says Approvals for drugs from ...

Biogen Inc. (NASDAQ:BIIB), a leader in biotechnology, announced the appointment of Sean Godbout as Vice President, Chief Accounting Officer & Global Corporate Controller, effective March 1, 2025 ...

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.

(Bloomberg) -- 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 ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena. The Office of the Inspector General at the ...

Biogen, the manufacturer of Aduhelm ... In addition to Aduhelm, the OIG found concerning the FDA's accelerated approval of two other drugs, Sarepta Therapeutics' Exondys 51 (eteplirsen), an antisense ...