FDA, ByHeart baby formula
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Pfizer faces a lawsuit in which women allege the drugmaker failed to warn them about the risks of meningioma associated with the birth control shot.
FDA Commissioner Dr. Marty Makary announces the acceptance of broader real-world data in medical applications, ending previous requirements that limited submissions.
The U.S. Food and Drug Administration (FDA) sent warning letters to several retailers for not removing recalled baby formula from their shelves.
The Food and Drug Administration (FDA) called on food industry companies to strengthen their recall compliance practices, less than a month after recalled ByHeart infant formula was found on shelves.
The FDA announced a voluntary recall of non-dairy frozen dessert pints sold at stores nationwide over the potential presence of small stones.
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche's drug, Perjeta, for the first-line treatment of patients with a type of breast cancer,
The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel) as the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS).
GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster.
The U.S. Food and Drug Administration has no plans to put a "black box" warning on COVID-19 vaccines, Bloomberg News reported on Monday, citing the agency's top official Marty Makary.