Fierce Biotech

‘Market’s thinking is backwards’: FDA’s 1-trial approval plan would boost R&D spend, Jefferies says

All this data builds Jefferies’ argument: the FDA change could help boost return on investment and therefore drive R&D spend.
News4Jax

Trump's plan for a drug advertising crackdown faces many hurdles

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) (Andrew Harnik, Copyright ...
Reuters

Groups say FDA's Plan B decision falls short of court order

NEW YORK (Reuters) - Reproductive-rights groups that sued the Food and Drug Administration over access to the "morning-after" pill will ask a judge to hold the agency in contempt if it fails to comply ...
MarketWatch

Tharimmune Shares Drop Premarket Following FDA Feedback on Plan for Lead Clinical Asset

Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling ...

Top FDA official Pazdur raises alarm about expediting approvals, Washington Post reports

The U.S. Food and Drug Administration's new head of the drug evaluation department, Richard Pazdur, has raised concerns about ...
Morningstar

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform FDA clearance marks a pivotal milestone in ViTAA’s broader AiORTA™ suite, ...
KTLA

Atossa Therapeutics Announces Positive FDA Feedback, Advances Toward IND for (Z)-Endoxifen Clinical Program in ER+/HER2- Metastatic Breast Cancer

SEATTLE, July 29, 2025 /PRNewswire/ --Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, today announced positive written ...