Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
Fierce Pharma18h
For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...
Messenger-Inquirer1d
Redefining 'Healthy:' The FDA’s new standards for food labels
When grocery shopping, you may notice food packages labeled as “healthy.” This term is meant to help buyers easily identify ...
Type of Trader Joe’s salad dressing recalled for ‘labeling error’ amid possible undeclared allergens
A salad dressing sold at Trader Joe’s locations in 17 states and Washington, D.C., has been recalled because of a “labeling ...
FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.
Oncology Nursing News1d
Oncology Drugs Approved by the FDA in March 2025
The FDA approved several therapies in oncology in the month of March 2025. These drugs included treatments for ...
Food Safety News2d
New guide outlines allergen labeling requirements for businesses
The Food and Drug Administration has published new information for businesses seeking guidance on how to label foods that ...
Ground coffee recalled in 15 states for caffeine labeling error
The U.S. Food and Drug Administration (FDA) has recalled ground coffee sold in 15 states after finding it may have been wrongly labeled as decaffeinated.
FDA Approves Sanofi's Hemophilia Drug
The U.S. Food and Drug Administration on Friday approved Sanofi SA’s (NASDAQ:SNY) Qfitlia (fitusiran), the first antithrombin ...
The US approved an Alzheimer’s drug. Seven patients subsequently died.
Leqembi — sold through a partnership between Eisai Co. and Cambridge-based Biogen — is one of the first medications approved ...
Fierce Pharma2d
Judge levies $1.64B penalty on Johnson & Johnson in HIV drug marketing case
Nearly a year after a jury decided that Johnson & Johnson should be fined just over $150 million in a lawsuit alleging that ...
News80004d
Debate over the abortion pill mifepristone resurfaces after new FDA chief confirmed
A pill used in most U.S. abortions has been ensnared in politics for years, and many Americans wonder whether it will be restricted under the new Republican administration.