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The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk ...
Older adults can continue getting covid boosters, but not everyone who wants them can. You’re reading The Checkup With Dr.
On May 15, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of “a stronger, more systematic review process for food chemicals already on the market — especially those that ...
Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive ...
Incyte Corp.’s Zynyz (retifanlimab-dlwr) has received another U.S. FDA approval and put some distance between it and a 2021 ...
The FDA often issues warning letters after initially flagging its concerns to a company and determining the company’s ...
The FDA has released its report on the 2023 actions of its Core Outbreak Response and Evaluation network. The network’s mission is to find, stop and aid in the prevention of foodborne illness ...
He spent much of the pandemic criticizing the FDA’s and the Centers for Disease Control and Prevention’s response to the virus ... The agency approved the boosters based on blood samples and safety ...
saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter (“CRL”) from the FDA for the resubmission of the New Drug Application ...
the Corporation filed its formal response on May 5, 2025, to the clarification requests issued by the Autorité des marchés financiers (AMF). This submission is expected to satisfy the AMF’s ...
The cuts to the FDA have been so severe that it has been forced to halt its entire milk safety inspection program. Unsafe milk can carry listeria, salmonella, campylobacter, E. coli, and other deadly ...
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Stocktwits on MSNImmunityBio Stock Tumbles 18% After FDA Issues Refuse To File Letter: But Retail’s PositiveShares of ImmunityBio, Inc. (IBRX) tumbled 18% on Monday afternoon after the company announced that it received a Refuse to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding ...
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