The Health and Human Services Secretary directed the FDA to consider eliminating a pathway that allowed companies to "self-affirm" whether their ingredients are safe for consumption.

Gilead Sciences announced a significant milestone: the U.S. FDA accepted their New Drug Applications (NDAs) for lenacapavir ...

U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise ...

While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to ...

The FDA has accepted the resubmission of a BLA for odronextamab for the treatment of patients with relapsed/refractory ...

“It’s a six-month production cycle,” Offit told The New York Times. “So one can only assume that we’re not picking flu strains this year.” Despite the VRBPAC cancellation, the FDA says ...

today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) ...

The Food and Drug Administration abruptly canceled a critical ... “It’s a six-month production cycle,” Dr. Offit added in a separate interview with The New York Times.

TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN), a prominent player in the biotechnology sector with a market capitalization of $77.1 billion and annual revenue of $14.2 ...

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By Sheryl Gay Stolberg and Christina Jewett A panel of scientific experts that advises the Food and Drug Administration ... “It’s a six-month production cycle,” Dr. Offit said.

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its blockbuster cancer drug Keytruda in certain patients with head and neck cancer.