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Recall on 10 Million Lbs. of Peaches Gets Important FDA Update

Affecting 11 peach varieties, the event touched 39 states, serving as another reminder of how far downstream a single grower issue can ripple.
BioSpace

UPDATE: FDA disputes Capricor’s claims of Phase 3 success for DMD cell therapy

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor ...

Inside the FDA’s Push to Update Testosterone Therapy Labels on Prostate Cancer and Blood Pressure

Federal regulators are moving to rewrite the rulebook on testosterone replacement therapy, easing warnings that have shaped ...
Hosted on MSN

Smoothie recall update as FDA sets most serious risk level

A banana smoothie product recalled over concerns of potential salmonella contamination has been issued the highest of three risk classifications by the U.S. Food and Drug Administration. Honeyville ...

Cyclosporiasis update: FDA says earlier positive lettuce sample was 'false positive,' Taylor Farms recall remains

The FDA says the one sample of Taylor Farms lettuce that previously tested positive for the parasite was a “false positive.” ...
Nasdaq

Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., May 8, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period ...

Rocket Pharmaceuticals Announces Positive Clinical Safety Update from Initial Three Patients Treated with RP-A501 Under Modified Phase 2 Protocol for Danon Disease

Rocket Pharmaceuticals, Inc. (Rocket or the Company) (NASDAQ: RCKT), a fully integrated, commercial-stage biotechnology company advancing genetic medicines for rare and devastating diseases, focused ...
Las Vegas Sun

Gossamer Bio Announces FDA Regulatory Update and Reacquisition of Worldwide Rights Related to Seralutinib and Provides a Business Update

The termination dissolves the prior U.S. 50/50 profit share and returns ex-U.S. rights to Gossamer, giving the Company full operational control of development, manufacturing, commercialization, ...
Newsweek

Muffin recall update as FDA issues highest risk warning

See more of our trusted coverage when you search. Prefer Newsweek on Google to see more of our trusted coverage when you search. The FDA has issued an update to their muffin recall from February, ...

UPDATE: Americans Want FDA to End Peptide Roulette, New National Poll Finds

A new national survey of 1,000 adults finds that 52% feel they should be able to obtain peptides through a licensed U.S. pharmacy with a doctor's prescription, while only 3% oppose, and 45% are ...
RAPS

This Week at FDA: User fee update, Califf nomination, and more

Correction: This article was edited on 18 January 2022 to clarify the number of enforcement letters sent by the Office of Prescription Drug Promotion in 2021 Welcome to another edition of This Week at ...