FDA Related News

Pallone Asks GAO to Analyze RIF Impact on User Fees

House Energy and Commerce Committee ranking member Frank Pallone asks the Government Accountability Office to analyze how FDA paid for its reductions-...

FDA General

Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust

A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing t...

Human Drugs

Full Approval Given to Lilly's Retevmo

FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pediatric patients wit...

Human Drugs

FDA Updates Bioequivalence Guidance for Generic Topical Corticosteroids

FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical dermatologic cortico...

Human Drugs

Hearing to Examine FDA's Role in Strengthening U.S. Drug Development

The House Energy and Commerce Subcommittee on Health plans a hearing 7/15 to examine how FDA can help strengthen U.S. leadership in biomedical innovat...

Marketing

DTC Advertising Industry Braces for Potential End of Adequate Provision

DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provision standard could amount to a de facto ban on br...

Human Drugs

Ascelia Clarifies CRL on MRI Agent After Public Release

Ascelia Pharma pushes back against FDA's recent public release of a Complete Response Letter for its MRI contrast agent Orviglance.

EIRS/483s

GSKs Jemperli Trial Meets Endpoint in Rectal Cancer

GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients with mismatch repair-de...

Human Drugs

Draft Guidance Outlines Development Standards for Psychedelic Drugs

FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors with the agency's mos...

Human Drugs

FDA Approves At-Home Dosing of Leqembi for Alzheimer's

FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients to begin treatment ...