News

Lawmakers press FDA to target knockoff weight-loss drug
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
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.
PharmExec2d
Can AI Accelerate Clinical Review at FDA?
With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...
Cancer Therapy Advisor2d
FDA Denies Approval of Vusolimogene Oderparepvec for Advanced Melanoma
The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.
Managed Healthcare Executive3d
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 ...
New Atlas2d
New kidney injury warnings added to all GLP-1 drugs by FDA
The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...
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, ...
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.
Targeted Oncology4d
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 ...
PharmExec19h
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
The American Journal of Managed Care3d
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.