News

Houston-based Empower Pharmacy’s drugs raised red flags for FDA and other states, but not Texas
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
Lawmakers Press FDA to Target Knockoff Weight-Loss Drugs
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
Managed Healthcare Executive4d
FDA Delays Approval of Replimune’s Melanoma Therapy Despite Promising Trial Results
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
The Hearty Soul on MSN8h
Parkinson's Discovery Suggests We Could Have an FDA-Approved Treatment Already
Parkinson's is a progressive neurodegenerative disease that is currently incurable. It is typically only diagnosed once ...
Medscape2d
FDA Declines to Approve New Melanoma Therapy
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
FDA Delays Approval For Ultragenyx's Gene Therapy, But Not A Dealbreaker, Says Analyst
Ultragenyx's UX111 gene therapy faces FDA delay due to facility issues; analysts adjust price targets amid uncertain ...
Targeted Oncology5d
FDA Issues Complete Response Letter for Glofitamab in R/R DLBCL Combination Therapy
FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in ...
The American Journal of Managed Care4d
FDA Issues CRL for Vusolimogene Oderparepvec in Advanced Melanoma
The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.
Cancer Therapy Advisor3d
FDA Issues CRL for Glofitamab Combo in Rel/Ref DLBCL
The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.
BioSpace15d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Fierce Pharma12d
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
Fierce Pharma9d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...