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Eton Pharmaceuticals Announces FDA Approval and Upcoming Launch of KHINDIVI™, the First and Only FDA-Approved Hydrocortisone Oral Solution for Pediatric Patients
To report a suspected adverse event related to KHINDIVI, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at Undertreatment or sudden ...
kffhealthnews14d
FDA Layoffs Will Likely Force Cutbacks In Food And Drug Inspections
Also, President Donald Trump's tariff exemptions for pharma. CBS News: FDA Planning For Fewer Food And Drug Inspections Due To Layoffs, Officials Say Senior Food and Drug Administration leaders are ...
Morningstar14d
Eton Pharmaceuticals Announces U.S. FDA Approval for KHINDIVI™ (hydrocortisone) Oral Solution
• Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals ...
Monthly Prescribing Reference15d
Drug-Device Combo Therapy Under Review for Parkinson Disease
The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for ND0612 for the treatment of motor fluctuations in patients with Parkinson disease.
The Lancet15d
The need to strengthen the US Food and Drug Administration: US cuts threaten health care at home and abroad
More broadly, loss of capacity at the FDA threatens the delicate ecosystem of innovation that is responsible for finding new medicines and bringing them to patients. The FDA has a central role in ...
Eagle-Tribune16d
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration ...
Food Safety News16d
FDA warns seafood processors in Venezuela and South Korea about botulism risks
The full warning letter can be found here. Eden F&C Co. Ltd Boeun-gun, Chungcheongbuk-do, South Korea The U.S. Food and Drug Administration (FDA) has issued a warning letter to Eden F&C Co. Ltd ...
Today21d
FDA announces cucumber recall after salmonella outbreak sickens more than 20
and is under investigation by the U.S. Food and Drug Administration, the agency announced Monday. A May 19, 2025, news release from the FDA reports that 26 people across 15 states have become ...
Penn Live21d
FDA investigates salmonella outbreak involving cucumbers sold in Pa., elsewhere
The Food and Drug Administration (FDA) is warning consumers, distributors and retailers to not eat, sell or serve recently recalled cucumbers as they have been linked to a salmonella outbreak in ...
CBS News21d
Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials
The Food and Drug Administration says it has decided to ... repeat COVID-19 vaccine doses or boosters," Dr. Vinay Prasad, the FDA's new top vaccines official, said in a video posted by the agency ...
Teen Vogue22d
Selena Gomez & Benny Blanco’s Wedding: Invites, Food, Dress and Everything We Know So Far
“The only thing I've said straight up, as part of the food, is that I want Jake to do the challah.” Jake is Jake Cohen, Blanco's friend; he's a cook and cookbook author and “makes the best ...