FiercePharma5d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...
FDA bans Red 3 dye from food and drugs. A scientist explains the artificial color's health risks and long history
Red 3—also called FD&C Red No. 3, erythrosine or E127—has been widely used in food, cosmetics and pharmaceuticals since its ...
FDA formaldehyde ban in hair products on hold once again
A proposed ban on formaldehyde in chemical hair straightening products—linked to cancer and other health risks—has hit a ...
STAT5d
A next-generation form of chemotherapy wins FDA approval
Another day, another president. Good morning! Today, we hear from former FDA officials, who lay out what they think the agency will need to thrive under the new Trump administration. We learn more ...
CNN4d
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the ...
cnbctv183d
Laurus Labs' US arm gets Form 483 from FDA after 'adverse experience' probe
Drug firm Laurus Labs Ltd on Wednesday (January 22) said its wholly-owned foreign subsidiary Laurus Generics Inc (LGI), based in Berkeley Heights, New Jersey, has received a Form 483 from the US Food ...
cnbctv185d
Cipla's Goa facility receives single FDA observation following inspection
Following the inspection, the facility received one observation in Form 483. Cipla stated its commitment to working closely with the FDA to address the observation comprehensively within the ...