FDA Approves First Nasal Spray Flu Vaccine You Can Give Yourself at Home
The FDA has approved a nasal spray flu vaccine for home use. Here's how it works, and when it will be available.
FDA Recalls Gluten-Free Cake and Gives Risk Classification
The "mini raspberry lemon coffee cake" was recalled due to potentially containing undeclared wheat flour and walnuts.
FDA issues recalls on at least 16 food and drug items in September. Here's a list
The FDA has removed the following items from store shelves this September, including pet food, baby powder and Lactaid.
FDA’s proposed packaged food labels won’t fix our obesity epidemic
A clear FDA public education campaign could help shoppers make healthier choices. But it should first pay attention to the ...
US FDA approves GE HealthCare's diagnostic drug for heart disease
The U.S. Food and Drug Administration approved GE HealthCare's diagnostic drug for use in detection of coronary artery ...
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FDA Approves Updated COVID-19 Vaccine for 2024-2025 Season
The fall virus season is upon us, and the U.S. Food & Drug Administration just approved one of the newest tools to protect ...
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FDA Panel Votes for Limits on Gastric, Esophageal Cancer Immunotherapy
After hours of company pushback, FDA's Oncologic Drugs Advisory Committee voted that the benefit of immunotherapy in low or ...
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With post hoc analysis, BridgeBio touts case for acoramidis as FDA decision date draws near
BridgeBio Pharma has been on the road to redemption ever since its treatment for a rare and fatal heart condition, acoramidis ...
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FDA helps fund antimicrobial projects
WASHINGTON — The US Food and Drug Administration recently announced that it would help fund three projects to collect, ...
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Recent Biosimilar Approvals By the FDA
On August 23, 2024, the FDA approved Amgen’s aflibercept biosimilar PAVBLU (aflibercept-ayyh), a biosimilar of Regeneron’s EYLEA®. According to the approval letter, “Pavblu is indicated for ...
FDA Approves the First New Schizophrenia Drug in Decades
Developed by Karuna Therapeutics, which was subsequently acquired by Bristol Myers Squibb, the drug works in an entirely ...
EQS-News: Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)
Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz) Otulfi TM received FDA approval for both subcutaneous and intravenous formulations, to treat the same ...