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 ...
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 ...
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 ...
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 ...
WebMD5d
New Rosacea Treatment Option Approved by the FDA
The FDA has approved an antibiotic called minocycline for the treatment of rosacea in adults. The drug, which is taken orally ...
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 ...
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 ...
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 ...
Cancer Therapy Advisor2d
FDA Approves Obecabtagene Autoleucel for Adults With BCP-ALL
The FDA has approved obecabtagene autoleucel (Aucatzyl) to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Cure Today4d
FDA Approves MI Cancer Seek as Companion Diagnostic for Adult and Pediatric Patients With Cancer
MI Cancer Seek has received approval from the FDA as a companion diagnostic test to identify those who may benefit from ...
Syncona : Autolus Receives FDA Approval For AUCATZYL In Adults With Relapsed/Refractory B-ALL
Syncona Ltd (SYNC.L) said that its portfolio company Autolus Therapeutics announced that the U.S. Food and Drug Administration has ...
FDA Approves Renewal of Canalevia-CA1, Jaguar Health’s Drug for Chemotherapy-Induced Diarrhea in Dogs
CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA ...