Company

FDA

15 briefings tracked

The U.S. Food and Drug Administration (FDA) is the federal regulatory agency responsible for approving and overseeing the safety and efficacy of pharmaceutical treatments and medical innovations.

Recent FDA decisions have significantly impacted the biotech sector. The agency reversed a previous rejection of a gene therapy treatment, clearing a development pathway following leadership transitions. It has also approved the progression of Moderna's mRNA-based influenza vaccine through its regulatory review process. Additionally, the FDA has expanded access to more affordable medications by authorizing states including Colorado to import prescription drugs from Canada.

These regulatory actions demonstrate the FDA's central role in determining which treatments reach patients, with wide-ranging effects on biotech investment, drug pricing policy, and the development timeline for new medical technologies.

Latest on FDA

FDA Sends Its First AI-Focused Manufacturing Warning to Drugmakers

FDA Turns Down Tris Pharma's Narcolepsy Drug as Agenus Scraps Cancer Trial

FDA Rejects Hengrui-Elevar Liver Cancer Drug for a Third Time

FDA Reverses Course, Posts 14 Pharma Rejection Letters Online

Apnimed Files for Nasdaq IPO as FDA Weighs Its Sleep Apnea Drug

FDA Slaps Down Lundbeck Over Inflated Migraine Drug Claims

Galderma Hits FDA Wall on Anti-Wrinkle Drug as Kimball Snaps Up CDMO

MapLight's Autism Drug Misses in Phase 2, but the Company Isn't Giving Up

FDA Reverses Course Again, Clearing Regenxbio to Resubmit Gene Therapy

Regenxbio Will Resubmit Hunter Syndrome Gene Therapy to FDA — No New Study Required

FDA Advisory Panel Unanimously Backs Moderna's Flu Vaccine

FDA Reverses "Truly Evil" Gene Therapy Rejection After Official's Exit

uniQure Soars 66% as FDA Clears Path for Huntington's Gene Therapy

FDA Clears Path for Moderna's mRNA Flu Shot With No Major Red Flags

FDA Clears Colorado to Import Cheaper Drugs From Canada