A much-debated drug for Lou Gehrig’s disease won U.S. approval on Thursday from the Food and Drug Administration.
won U.S. approval on Thursday from the Food and Drug Administration., though it is likely to renew questions about the scientific rigor behind government reviews of experimental medicines, as the Associated Press has reported.
Typically, the FDA requires two large studies or one study with "very persuasive" survival results for approval.It's the third U.S.-approved medicine for the treatment of— which destroys nerve cells needed for basic functions such as walking, talking and swallowing. Amylyx’s drug is the latest in a series of neurological drugs that have won FDA approval despite questionable effectiveness data, according to the AP.
In early Sept., FDA advisers — reversing a previous decision — voted to recommend approval of the drug. Recently, however, the FDA faced a great deal of pressure from ALS patients, advocates and members of Congress, the AP noted. FDA approval is expected to compel insurers to cover Amylyx’s medication.
日本 最新ニュース, 日本 見出し
Similar News:他のニュース ソースから収集した、これに似たニュース記事を読むこともできます。
Judge green lights defamation lawsuit against Fox, Lou DobbsNEW YORK (AP) — A defamation lawsuit against Fox Corp., Fox News Network and Lou Dobbs can proceed toward trial, a judge ruled Monday after concluding that a Venezuelan businessman had made sufficient claims of being unfairly accused of trying to corrupt the 2020 U.S.
続きを読む »
Judge Green Lights Defamation Lawsuit Against Fox, Lou DobbsA defamation suit against Fox Corp., Fox News Network and the former Fox Business host can proceed to trial.
続きを読む »
Judge OKs Venezuelan Man's Defamation Suit Against Fox, Lou DobbsBusinessman Majed Khalil is suing Dobbs and Fox News over claims made on “Lou Dobbs Tonight” accusing Khalil of trying to corrupt the 2020 U.S. presidential election..
続きを読む »
New Alzheimer's Drug Appears to Actually Work, to Some DegreePharmaceutical developers Biogen and Eisai want to fast-track a new Alzheimer's drug, lecanemab, for FDA approval — but it's been met with mixed opinions.
続きを読む »
Alzheimer's-slowing drug labelled historicThe drug appears to reduce the pace of the disease, in early data from clinical trials.
続きを読む »