Fierce Pharma
Fierce Biotech
Fierce Healthcare
Fierce Life Sciences Events
Advertise
About Us
Pharma
Vaccines
Asia
Cell & Gene Therapy
Drug Delivery
Executives
Manufacturing
Facilities
Recalls
Warning Letters
Marketing
Special Reports
Fierce 50
Special Report
Awards Gala
Resources
Podcasts
Fierce Events
Industry Events
Webinars
Whitepapers
Survey
Events
Subscribe
Subscribe
Pharma
Vaccines
Asia
Cell & Gene Therapy
Drug Delivery
Executives
Manufacturing
Facilities
Recalls
Warning Letters
Marketing
Special Reports
Fierce 50
Special Report
Awards Gala
Resources
Podcasts
Fierce Events
Industry Events
Webinars
Whitepapers
Survey
Events
Subscribe
Fierce Pharma
Fierce Biotech
Fierce Healthcare
Fierce Life Sciences Events
Advertise
About Us
Richard Pazdur
Pharma
FDA looks to clarify follow-up testing mandate for speedy nods
In a draft guidance document, the FDA specified criteria to determine whether a confirmatory trial is “underway” prior to an accelerated approval.
Angus Liu
Jan 6, 2025 3:36pm
2023 forecast: FDA revamps cancer drug approvals
Dec 21, 2022 5:00am
Most influential people in biopharma—the regulators and advocates
May 23, 2022 3:00am
FDA oncology chief, Senate bill, Insilico—Fierce Pharma Asia
Apr 1, 2022 9:35am
FDA oncology czar defends rejection of Lilly-Innovent PD-1
Mar 28, 2022 11:34am
Lilly promises 40% discount for PD-1, heaping pressure on FDA
Feb 10, 2022 11:45am