Hosted on MSN23h
US FDA declines full approval for Intercept's liver disease drug
The drug, Ocaliva, will continue to be available in the U.S. under the accelerated approval status, the company said. Under ...
MedPage Today1d
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 ...
US FDA approves Johnson & Johnson's device for heart condition
The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...
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 ...
FierceBiotech8h
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 ...
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 ...
dvm36019h
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 ...
Autolus secures FDA approval for CAR-T cell therapy use in ALL
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy ...
Yahoo16h
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 ...
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 ...
Pharmaceutical Technology2d
Dizal seeks FDA approval for NSCLC treatment sunvozertinib
Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure ...
MarketWatch3h
GE HealthCare Gets FDA Approval For Head-Only MRI Scanner
That approval pathway is for devices that are similar to products that are already approved for market. GE HealthCare said the system would offer new capabilities in clinical imaging and neuroscience ...