FierceBiotech8h
FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...
Stockhouse3h
Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
The Company’s current customer segments outside the US include construction, manufacturing and engineering, ...
FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
FDA to pull common but ineffective cold medicine from market
The FDA says oral phenylephrine, used in many over-the-counter cough and cold medicines, "is not effective as a nasal ...
FiercePharma23h
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
Atlanta Journal-Constitution2d
FDA proposes pulling decongestants from shelves over one ingredient
For some products, it is the only ingredient, the FDA said in a news release issued Thursday. Others contain oral phenylephrine and acetaminophen, dextromethorphan or another active ingredient.
FDA seeks to remove ingredient from cold medicines after data shows it does not work
The U.S. Food and Drug Administration is taking the first step to remove an ingredient in non-prescription cold medicines ...
FDA proposes ending use of decongestant found in many cold, allergy medicines
An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.
dvm36020h
FDA approves renewal for canine chemotherapy-induced diarrhea treatment
Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved ...
BioPharma Dive2d
FDA approves new CAR-T competitor to Gilead’s Tecartus
Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...
Stockhouse3h
Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables
This project aims to use the GastroPlus PBPK platform to investigate the intricate relationship between LAI formulation critical quality attributes (CQAs) and physiological factors at the injection ...
dvm36019h
Buprenorphine extended-release injectable suspension now available for use in captive rodents and laboratory rabbits
Ethiqa XR now includes captive rodents and laboratory rabbits for 72-hour post-procedural pain management on its label ...