The drugs and devices have been on the market for years, but FDA-ordered studies still aren't done

When the U.S. Food and Drug Administration (FDA) was deciding whether to approve the drug Tavneos several years ago to treat ...
Cardiovascular Business

FDA approves first sirolimus drug-eluting balloon for in-stent restenosis

The newly approved device from Cordis provides therapy over an extended period of time without leaving a permanent implant ...

Elevar Therapeutics Receives FDA Conditional Acceptance of LYRFIGTU as Brand Name for Lirafugratinib

PDUFA date of September 25, 2026 Lyrfigtu (lirafugratinib) achieved a 46% ORR, in CCA patients with FGFR2 fusion or other ...

FDA panel puts Grail’s cancer screening to the test

A panel of outside advisers will vote this week on whether to recommend that the Food and Drug Administration grant the first domestic premarket approval for a multicancer early-detection blood test.

FDA-ordered studies of many drugs, devices on the market are not done

To get drugs and devices out faster, the FDA lets companies conduct studies of safety or efficacy after the products are ...

FDA fills four senior roles, including top officials for drugs, vaccines and tobacco

WASHINGTON (AP) — The administration of President Donald Trump filled four senior positions at the Food and Drug Administration on Tuesday, promoting several officials who had been serving in acting ...
JD Supra

SEC-FDA Information-Sharing MOU: Implications for Pharma and Biotech

The US Securities and Exchange Commission (SEC) and the US Food and Drug Administration (FDA) recently signed a joint memorandum of ...
BioSpace

KVK-Tech Completes FDA REMS Inspection with No Observations

The Opioid Analgesic REMS is an FDA-required program for opioid analgesics intended for outpatient use. It is designed to ...
STAT

HHS unveils new initiatives to reduce animal testing in drug development

For the second time this year, HHS announced new strategies to speed the away from animals in medical testing.