FDA News

This Week’s Biopharma News: New Approvals, Appeals, and AI

FDA · 10 min

Celcuity's Gedatolisib: Navigating the Path to Broad FDA Approval in Breast Cancer

FDA · breast cancer · 8 min

FDA Delays Decision on AstraZeneca's Camizestrant Following Negative Adcomm Vote

FDA · breast cancer · 9 min

Navigating FDA's Clinical Trial Transparency Enforcement: A Practical Guide for Sponsors and Sites Post-April 2026

FDA · 9 min

FDA Declines Cingulate's ADHD Drug CTx-1301 Over Manufacturing Concerns

FDA · ADHD · 9 min

STAT+ Pharmalittle: Lilly's 340B Hospital Threat, Ebola Vaccine Funding, and More

Ebola · 7 min

This Week in Breast Cancer: Camizestrant Delay, Bria-IMT Data, Recurrence Test

FDA · breast cancer · 9 min

Vyome Holdings Q1 2026: FDA Filings and Financial Strength Signal Strategic Momentum

FDA · 10 min

FDA Clears Iovance IL-12 TIL Trial, Signaling New Frontier in Solid Tumor Therapy

FDA · 8 min

FDA Approves Ensitrelvir for Post-Exposure Prophylaxis of COVID-19

FDA · COVID-19 · 8 min

AbiVax falls as safety worries cloud ‘landmark’ immune drug results

FDA · ulcerative colitis · 7 min

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

FDA · cell and gene therapies · 7 min