Drug approvals

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File)

Speedier drug approvals hit slowdown as FDA faces scrutiny

The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs.
 
This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. (Biogen via AP)

Medicare copays for new Alzheimer’s drug could reach $11,500

 
President Donald Trump attends a teleconference with governors at the Federal Emergency Management Agency headquarters, Thursday, March 19, 2020, in Washington. Vice President Mike Pence is at right. (AP Photo/Evan Vucci, Pool)

AP FACT CHECK: Trump falsely claims drug approval for virus

 
This photo provided by Novartis shows their gene therapy medicine Zolgensma. U.S. regulators want to know why Novartis didn't disclose a problem with testing data until after they approved the Swiss drugmaker’s $2.125 million gene therapy. On Tuesday, Aug. 6, 2019, the Food and Drug Administration said the questionable data involves testing of the therapy, Zologensma, on animals, not on patients. (Novartis via AP)

FDA says Novartis withheld data problem before drug approval

 

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