Lundbeck gains FDA fast track designation for MSA therapy amlenetug
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Monthly Prescribing Reference4h
FDA Grants Fast Track Status to PP-01 for Cannabis Withdrawal Syndrome
The Food and Drug Administration (FDA) has granted Fast Track designation to PP-01 (nabilone/gabapentin) for the mitigation of cannabis withdrawal ...
Targeted Oncology2d
FDA Fast Tracks Amezalpat for HCC Treatment
Amezalpat received fast track designation from the FDA for the treatment of patients with hepatocellular carcinoma.
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis
Biodexa Receives US FDA Fast Track Designation for eRapa in Familial Adenomatous Polyposis Underscores unmet need for a ...
Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCCAmezalpat builds momentum with both ...
Pharm Exec8d
FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus
The FDA has granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy, for ...
Targeted Oncology7d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Monthly Prescribing Reference2d
Encapsulated Rapamycin Fast Tracked for Familial Adenomatous Polyposis
The Fast Track designation is supported by data from a phase 2 trial that evaluated eRapa in 30 adult patients with FAP.
Nektar receives FDA Fast Track Designation for rezpegaldesleukin
Therapeutics announced that the U.S. FDA has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and ...
Biodexa Pharmaceuticals ADRs Rise After Cancer Drug Gets FDA Fast-Track Designation
The U.K. biopharmaceutical company said data from a Phase 2 study of eRapa, a treatment for familial adenomatous polyposis, showed the drug to be safe and well-tolerated among users. The treatment ...
Renal & Urology News2d
Gamma Delta CAR T-Cell Therapy Fast Tracked for SLE With Extrarenal Involvement
The FDA has granted Fast Track designation to ADI-001 for the treatment of refractory systemic lupus erythematosus with extrarenal involvement.