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FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
FDA Issues Risk Warning as Apples Recalled in Four States
A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...
MedPage Today on MSN19h
A 'Culture Change' Is Needed in Academic Medicine, FDA Commissioner Says
The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...
FDA to end dozens of 'obsolete' rules for U.S. food items
The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also include "unnecessary" ones.
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FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
MedPage Today on MSN19h
Myeloma Drug's Comeback Nixed by FDA Panel
The comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee ...
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The FDA lets ‘risky drugs’ into the U.S. market, ProPublica reporter explains their investigation
The team spent 14 months investigating and found that the FDA had allowed more than 150 potentially unsafe drugs in the U.S.
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FDA Commissioner: ‘We want to focus on food’
“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...
F.D.A. Approves Juul Vapes After Yearslong Delay
The Food and Drug Administration authorized Juul e-cigarettes for the U.S. market on Thursday, ending a lengthy standoff with ...