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The Latest Breaking News from U.S. Food and Drug Administration

Why NeuroSense Shares Are Soaring Today

NeuroSense Therapeutics Ltd (NASDAQ: NRSN) shares are soaring Monday after the company announced it received U.S. Food and Drug Administration clearance to initiate a pharmacokinetic study of PrimeC in healthy adult subjects.

Benzinga · Mar 21, 2022

Abbott facing lawsuits, FDA investigation over recalled infant formula after reports of illness, death

Parents who bought recalled infant formulas made by Abbott Laboratories are filing proposed class-action lawsuits against Abbott, as the U.S. Food and Drug Administration investigates reports of three babies who became sick and two who died after consuming the formulas.

Chicago Tribune · Mar 2, 2022

Why Pfizer Shares Are Trading Higher Today

Pfizer Inc (NYSE: PFE) is trading higher Wednesday after the company received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for PF-06482077, or RSVpreF, the company's respiratory syncytial virus vaccine candidate.

Benzinga · Mar 2, 2022

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Editorial: FDA should pull ineffective pregnancy drug Makena until we know it works

The U.S. Food and Drug Administration accelerated the approval of a drug called Makena meant to prevent premature births. Now there’s mounting evidence that the drug does not work. The FDA should use its authority to pull Makena from the market until and unless the company that makes it can…

Los Angeles Times · Feb 25, 2022

FDA authorizes first condom specifically marketed for anal sex

The U.S. Food and Drug Administration on Wednesday announced its first-ever authorization of a condom specifically meant for anal sex.

Tribune News Service · Feb 23, 2022

FDA Will Foster Development Of Non-Addictive Alternatives To Opioids For Pain: Should Cannabis Be On The List?

The U.S. Food and Drug Administration (FDA) announced Wednesday that it is taking steps aimed to foster the development of non-addictive alternatives to opioids to manage acute pain and prevent new addiction. The agency issued draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain.

Benzinga · Feb 9, 2022

Moderna gains full FDA approval for COVID-19 vaccine while Novavax makes push for its own shot

WASHINGTON — Moderna Inc.’s vaccine for COVID-19 received full approval from the U.S. Food and Drug Administration for people 18 and older, an important milestone that bolsters the shot’s use as a major weapon against the virus.

Tribune News Service · Jan 31, 2022

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Why Moderna Shares Are Rising Today

Moderna Inc (NASDAQ: MRNA) is trading higher Monday after the U.S. Food and Drug Administration approved the Biologics License Application for SPIKEVAX to prevent COVID-19 in individuals 18 years of age and older.

Benzinga · Jan 31, 2022

GOP state senator in Georgia files bill that would ban mailing of abortion pill

ATLANTA — A Republican state senator has filed legislation to fight a decision by the U.S. Food and Drug Administration allowing those with a prescription to obtain the abortion pill through the mail.

Tribune News Service · Jan 25, 2022

FDA: Medtronic slow to update, recall defective insulin pumps for diabetes patients

While the U.S. Food and Drug Administration acknowledges Medtronic is actively working on fixing issues within its diabetes business, especially in regard to some of its insulin pumps, it says the steps took too long and are not enough.

Tribune News Service · Jan 17, 2022

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