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.
Las Vegas Sun6d
Juul’s FDA approval doesn’t clear fog of e-cigarette risks, especially for teens
The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...
Fierce Biotech4d
Replimune's shares crater as FDA rejects melanoma drug
The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...
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 ...
Cancer Therapy Advisor3d
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.
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, ...
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 ...
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.