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FDA
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7 days ago
Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.
8 days ago
FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals ○
Makary pointed to three bottlenecks: hospital contracting, ethical reviews and approvals and the Investigational New Drug applications process
9 days ago
FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal ⊖
The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.
FDA chief Marty Makary says 'everything should be over-the-counter' unless drug is unsafe or addictive ⊕
Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.
U.S. FDA reverses course, will review Moderna's modified flu vaccine application ○
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine application, reversing an earlier decision.
13 days ago
What signal Lilly sends by stockpiling its GLP-1 weight loss pills ahead of FDA approval ⊕
Every weekday, the Investing Club releases the Homestretch; an actionable afternoon update just in time for the last hour of trading.
15 days ago
US FDA declines Moderna flu vaccine review amid vaccine guidance rollback ⊖
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a story from Al Jazeera 🚨 › Al Jazeera English
CEO Stephane Bancel said the letter refusing review did not cite 'any safety or efficacy concerns'.
16 days ago
Moderna says FDA refuses to review its application for experimental flu shot ⊖
Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called mRNA-1010.
17 days ago
FDA says Novo Nordisk's TV ad for obesity pill includes 'false or misleading' claims ⊖⊖
The FDA requested that Novo take immediate action to address the violations, which could include ceasing all ads containing misleading claims about the pill.
19 days ago
Hims & Hers abandons copycat weight-loss drug in face of FDA probe ⊖
Novo Nordisk had accused the telehealth company of breaching its patent on Wegovy