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Stay current with all the latest and breaking news about FDA, compare headlines and perspectives between news sources on stories happening today. In total, 547stories have been published about FDA which Ground News has aggregated in the past 3 months.

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Moderna’s Covid Vaccine Gets Full FDA Approval For Use In Children 6 Months And Older

Moderna · United States

Moderna’s Covid Vaccine Gets Full FDA Approval For Use In Children 6 Months And Older

62% Center coverage: 39 sources

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, the company said on Thursday.See the Story

Why Is Capricor Therapeutics Stock Trading Lower On Friday? - Capricor Therapeutics (NASDAQ:CAPR)

FDA · United States

Why Is Capricor Therapeutics Stock Trading Lower On Friday? - Capricor Therapeutics (NASDAQ:CAPR)

67% Center coverage: 6 sources

Capricor Therapeutics Inc. (NASDAQ:CAPR) stock is trading lower on Friday. The company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In the CRL, the FDA stated that it had completed its application review but could not approve…See the Story

Just How Radical Is the FDA's Complete Response Letter Move?

Pharma · United States

Just How Radical Is the FDA's Complete Response Letter Move?

60% Center coverage: 5 sources

The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.See the Story

Blindspots

RNA-Seq Analysis of Human Heart Tissue Reveals SARS-CoV-2 Infection and Inappropriate Activation of the TNF-NF-κB Pathway in Cardiomyocytes

FDA Approves Merck's BRAVECTO QUANTUM Annual Flea And Tick Shot For Dogs

75% Center coverage: 4 sources

STOCK PHOTO/Getty Images (WASHINGTON) — Dogs across the U.S. could soon get longer-lasting protection against pesky parasites thanks to a new treatment approved by federal regulators Thursday. The U.S. Food and Drug Administration has given the green light to Bravecto Quantum, the first-ever flea and tick preventative that can protect dogs for up to 12 months with a single injection. The treatment is approved for dogs and puppies 6 months and ol…FDA · Washington See the Story

FDA Ends Recall of Salmonella-Contaminated Brown Eggs

Coverage: 4 sources

The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs has ended, the Food and Drug Administration announced on Thursday.FDA See the Story

Listeria threat forces mushroom recall

100% Center coverage: 1 sources

CLEVELAND, Ohio – Mushrooms distributed in Ohio and Michigan have been recalled because of a threat of Listeria contamination, according to the Food and Drug Administration.FDA · Cleveland Read Article

U.S. Sen. Deb Fischer Says She Steered $17.5 Million to Nebraska in Senate Ag Funding Bill

100% Center coverage: 2 sources

The Senate ag funding bill is at odds with Trump, who wants to cut spending on USDA and FDA for the next fiscal year.Donald Trump · United States See the Story

Pharmacists Are Key to Expanding Medicaid Access to Digital Therapeutics – RamaOnHealthcare

More than 78 million Americans rely on Medicaid or CHIP for their health care. Yet many still cannot access FDA-approved digital therapeutics because their state does not include them in covered benefits.Prescription digital therapeutics (PDTs) are software-based treatments authorized by the FDA. They are delivered through smartphones or tablets and are used to manage conditions [...]Health Care · United States See the Story

Lupin receives FDA approval for generic Lotemax

Loteprednol etabonate ophthalmic gel, 0.38%, is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.FDA · United States Read Article

FDA Staff Cuts Slow Overseas Drug Inspections - Legal Reader

100% Left coverage: 1 sources

Staff cuts and lost experience strain FDA oversight of overseas drug factories.FDA · United States See the Story

Biotech CEOs to FDA: Don’t Let Politics Override Science on Abortion Pill

100% Left coverage: 1 sources

Fifty-three biotechnology industry leaders and investors representing dozens of companies and organizations issued a letter late last month advising the U.S. Food and Drug Administration: Follow the science on mifepristone, not political ideology. The Biotech CEO Sisterhood initiated the letter, with Grace Colón as lead author and dozens of senior biotechnology leaders signed on in support. “We are urging the agency and the department to continu…FDA · United States Read Article

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