Fierce Pharma3d
Cellares' cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s ...
American Hospital Association3d
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have ...
National Law Review4d
In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests
In the never-ending saga over the battle to regulate laboratory-developed tests (LDTs), the Eastern District of Texas took ...
Cero Therapeutics receives FDA clearance of second IND application for CER-1236
CERo Therapeutics (CERO) announces that the Company has received clearance by the U.S. Food and Drug Administration, FDA, for a second ...
New Atlas16d
Breakthrough stroke drug heals the brain to restore movement
The drug, tested on mice, restored these gamma oscillations, and in turn reconnected neurons to essentially heal the brain damage without arduous physical rehabilitation.
CBC.ca25d
Regina woman is living proof of 'breakthrough' ALS drug now approved in Canada
Dr. Genge said this treatment is already inspiring other research on therapies for forms of ALS not caused by SOD1, as well as the drug's impact on people who have the gene mutation but have ...
Channel NewsAsia Singapore25d
What happened in Philippine drug war that led to Duterte's arrest?
His profanity-packed speeches and death threats to drug gangs were a feature of his ... and compared the remains with death certificates and official reports. Dozens of cases showed violent ...
Investopedia26d
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators. The company noted the FDA held inspections of its San Diego, Calif., ...
Reuters26d
Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
March 10 (Reuters) - U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise safety rules to help eliminate a provision that ...
JD Supra26d
Health Care Week in Review | Senate Holds Hearings for NIH and FDA Nominees; CMS, HRSA, and SAMHSA Advise Against Forms of Gender-Affirming Care
Note: For many Executive Office of the President (EOP) actions, the stated day reflects when the action was submitted to the Federal Register, not when it was first released by the White House.
Business Standard27d
Alembic Pharma's Vadodara facility gets one Form 483 observation from US FDA
Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the companys aforementioned unit. The company will provide comprehensive response to US ...
CBS News29d
How the FDA lets chemicals pour into America's food supply
In a memo dated Sept. 9, 2024, an FDA toxicologist said Psyched Wellness' claim of GRAS certification was false. The firm failed to show that its extract was generally recognized as safe ...