Capricor projects FDA priority review decision for deramiocel by August 2025
Q4 2024 Management View CEO Linda Marban highlighted the acceptance by the FDA of Capricor's Biologics License Application (BLA) for deramiocel, targeting treatment of Duchenne muscular dystrophy (DMD ...
ABC278h
Food safety legislation would require warning labels for some dyes and chemicals
New bipartisan legislation would increase awareness about what’s in food. Products that contain certain dyes and chemicals would be required to have warning ...
scPharmaceuticals Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Pharmaceuticals generated fourth quarter 2024 net FUROSCIX® revenue of $12.2 million, and full year 2024 revenue of $36.3 millionCash and cash ...
This cutting edge hair loss treatment is a repurposed drug from the 1990s
A hair loss drug that first gained popularity in the 1990s is seeing a resurgence of interest. Minoxidil is best known as the ...
Zacks Investment Research on MSN14h
JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease
Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, nipocalimab, for treating adult patients with moderate-to-severe Sjögren’s ...
FDA allows companies to decide what food additives are safe. That may be changing.
The Food and Drug Administration lets companies self-report whether a chemical they add to food is safe. That may be changing ...
Healio5d
FDA approves expanded label for Iluvien
The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...
FBI issues safety warning about counterfeit versions of weight loss drug semaglutide
Wegovy contains the same main ingredient as Ozempic, semaglutide, and is FDA-approved for weight loss in people with obesity or who are overweight with at least one weight-related condition. It is ...
ANI Pharmaceuticals announces FDA approval for expansion of Iluvien label
ANI Pharmaceuticals (ANIP) announced that the U.S. FDA has approved an expanded label for Iluvien that includes an indication for the treatment ...
Access to Compounded GLP-1s Is Drying Up. Here’s What to Know About the Copycat Weight-Loss Drugs.
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
Medscape17d
Provisional Observations on Drug Product Shortages: Effects, Causes, and Potential Solutions
When the primary use of a product is an unlabeled use -- an indication not listed in the FDA-approved labeling -- it can be especially difficult to get information about a shortage. Manufacturing ...