US FDA approves expanded use of Lilly's bowel disease drug
Eli Lilly said on Wednesday the U.S. health regulator has approved its drug to treat adults with moderate-to-severe Crohn's ...
Incyte And Syndax : FDA Approves Niktimvo 9 Mg And 22 Mg Vial Sizes
Incyte (INCY) and Syndax Pharmaceuticals (SNDX) announced that the U.S. Food and Drug Administration has approved Niktimvo ...
Santa Rosa Press Democrat8h
Gov. Newsom committed California to making its own insulin. It’s at least a year behind his schedule
Gov. Newsom in 2020 signed a law allowing California to manufacture its own insulin, an effort to bring down the cost of the ...
Incyte's and Syndax's Graft Disease Treatment Niktimvo Gets FDA Approval for Vial Sizes
Incyte and Syndax Pharmaceutical said the Food and Drug Administration approved their graft disease treatment Niktimvo antibody in nine milligram and 22 milligram vial sizes.
Becker's Hospital Review9h
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
When must Red Dye No. 3 be removed from US foods after FDA ban? Latest timing
Regulators banned a dye called Red 3 from the U.S. food supply, but the timing for its removal won't be immediate.
Cure Today10h
The Subcutaneous Approval of Opdivo Makes Waves in Future of Cancer Care
Subcutaneous Opdivo improves cancer care by offering faster, accessible therapy, reducing time toxicity and expanding patient ...
Eli Lilly Receives FDA Approval for Crohn’s Disease Treatment
Eli Lilly said it received Food and Drug Administration approval for its treatment for moderate to severely-active Crohn’s ...
Cowboy State Daily11h
Montana Fitness Guru Faces Jail For Selling Unapproved Drugs To Fight Man Boobs
A Montana fitness-based business owner faces jail time for illegally selling bodybuilding drugs that fight "man boobs." He ...
JD Supra12h
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
FDA bans red dye No. 3 from foods
The ban removes it from the list of approved color additives in foods, dietary supplements and oral medicines, such as cough ...
ophthalmologyadvisor13h
FDA Alerts: Ophthalmology Drug and Device Approvals
FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.