FDA

GSK’s lung cancer drug shows 94% response rate in frontline trial

GSK presented data on Monday at the 2026 World Conference on Lung Cancer in Seoul showing that its ROS1 inhibitor Jideytro, known generically as zidesamtinib, produced a 94% objective response rate in patients with advanced ROS1-positive non-small cell lung cancer…

AstraZeneca caps milestone week with FDA nod, COPD data

AstraZeneca secured accelerated FDA approval for its breast cancer drug Etcamah (camizestrant), capping a week of clinical milestones for the British-Swedish drugmaker that included positive late-stage data for a COPD treatment it expects could generate more than $5 billion in…

FDA clears Roche, Eli Lilly blood test for Alzheimer’s

The U.S. Food and Drug Administration has cleared a blood test developed by Roche in collaboration with Eli Lilly that can help detect signs of Alzheimer's disease through a simple blood draw, potentially transforming how the condition is diagnosed across…

FDA clears Samsung Galaxy Buds as over-the-counter hearing aids

Samsung announced Tuesday that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration, allowing compatible earbuds to function as over-the-counter hearing aids for adults with perceived mild to moderate hearing loss.

FDA panel meets Wednesday to vote on access to seven unproven peptides

The Food and Drug Administration's Pharmacy Compounding Advisory Committee will convene on July 23–24 to vote on whether seven popular but unapproved peptides should be added to the Section 503A Bulk Drug Substances List, a move that would allow licensed…

FDA authorizes OraSure’s rapid test for Bundibugyo Ebola virus

The FDA on Tuesday granted Emergency Use Authorization to OraSure Technologies for its OraQuick Ebola 2.0 Rapid Antigen Test, a second-generation diagnostic capable of detecting the Bundibugyo virus driving the current Ebola epidemic in Central Africa.

FDA approves Trodelvy for first-line metastatic breast cancer

The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences' Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of metastatic triple-negative breast cancer, a decision that establishes the antibody-drug conjugate as a new standard of care for one of the…

Paradromics implants first long-term brain chip in FDA speech-restoration study

Paradromics, an Austin-based neurotechnology company, has implanted its Connexus brain-computer interface in the first participant of its FDA-approved clinical study, marking a milestone in the company's nearly decade-long effort to restore speech for people with severe motor impairments.