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First Pill for Postpartum Depression Is Approved by FDA
The pill, to be taken daily for at least two weeks, significantly reduced postpartum depression among new mothers in a recent trial. Source link
Juul Has a New High-Tech Vape and Hopes the FDA Won't Ban It
The e-cigarette maker is seeking U.S. authorization for a next-generation device, while waiting for word on whether its current products can stay on the market.
FDA Approves First RSV Drug to Protect All Infants
While the virus often leads to mild, coldlike symptoms, it is the leading cause of hospitalization of infants in the U.S. Source link
FDA Approves First Over-the-Counter Birth-Control Pill
The Food and Drug Administration approved the first over-the-counter birth-control pill, significantly expanding access to contraception among women across the U.S. Source link
FDA Approval Isn't Always a Happy Day for Biotech Investors
In recent weeks, three closely watched FDA decisions came in positive for the companies—followed by their stocks going negative. Source link
Biogen stock whipsaws despite FDA granting full approval for Alzheimer’s drug; analysts explain why By Investing.com
© Reuters. FDA converts Biogen and Eisai’s Alzheimer’s treatment to traditional approval The U.S. Food and Drug Administration (FDA) converted the approval status of Leqembi
US FDA grants standard approval of Eisai/Biogen Alzheimer’s drug By Reuters
© Reuters. FILE PHOTO: The Alzheimer’s drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File
FDA Approves Leqembi, Extending Alzheimer's Treatment to More Patients
Medicare enrollees can get the anti-amyloid treatment as a result of the agency’s full approval. Source link
FDA Forces the Only Drug for Preterm Births to Leave Market
Health Makena injections for pregnant women with previous early births are ineffective, agency says Source link
FDA Accepts SNDAs For Pfizer’s BRAFTOVI + MEKTOVI
(RTTNews) – Pfizer Inc. (PFE) Tuesday said the Food and Drug Administration accepted Supplemental New Drug Applications (sNDAs) for BRAFTOVI plus MEKTOVI for patients with