We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling. Read More
Insurers need more evidence of long-term safety and efficacy to make the best decisions about whether — and how — to cover Eisai’s Leqembi (lecanemab) for early Alzheimer’s disease, according to experts who participated in a policy discussion with the Institute for Clinical and Evidence Review (ICER). Read More
The FDA appears to be casting a favorable eye on Biogen’s SOD1-amyotrophic lateral sclerosis drug tofersen, suggesting that reductions in neurofilament light, a protein associated with neuronal damage, could support an Accelerated Approval. Read More
If approved, the candidate could provide the broadest meningococcal serogroup coverage thus far, and could lead to a simplified immunization schedule. Read More
To disrupt the high-cost insulin market, the state of California is teaming up with nonprofit generic drug manufacturer Civica Rx to make insulins that will become available at low cost. Read More
CDER’s Office of Compliance issued 101 warning letters in fiscal 2022 — about two-thirds of them related to COVID-19 products, according to the office’s latest annual report. Read More
BioNTech and OncoC4 have inked a deal that has BioNTech paying $200 million upfront to co-develop and commercialize OncoC4’s anti-CTLA-4 monoclonal antibody candidate as a monotherapy or combination therapy for various cancers. Read More