US FDA declines full approval for Intercept's liver disease drug
By Bhanvi Satija and Puyaan Singh (Reuters) - The U.S. Food and Drug Administration on Tuesday declined full approval for ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
The U.S. Food and Drug Administration approved PTC Therapeutics' gene therapy to treat a potential fatal enzyme deficiency ...
MedPage Today2d
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...
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 ...
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 ...
Yahoo1d
FDA approves software to turn Appke Airpods into hearing aids
The Food and Drug Administration (FDA) recently gave Apple the green light to use software that may help million of people ...
News Medical14h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...
FiercePharma1d
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 ...
FierceBiotech1d
Caris scores FDA approval for multi-cancer companion diagnostic test
Caris Life Sciences has obtained an FDA approval for its MI Cancer Seek tumor profiling assay, unlocking its use as a ...
dvm3601d
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 ...
Monthly Prescribing Reference17h
FDA Denies Full Approval of Obeticholic Acid for Primary Biliary Cholangitis
The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.