News

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 ...
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 Sun5d
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 Biotech3d
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 ...
JD Supra9h
Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ ...
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 Atlas1d
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 ...
Medscape1d
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 Advisor2d
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.
Applied Clinical Trials Online10h
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Tech Times1d
FDA's Elsa AI Hallucinates Studies, Says Employees: Double-Checking Facts Is a Must
The FDA's generative AI, Elsa, has a massive hallucination problem, according to the agency's employees themselves.
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 ...