JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
BioSpace

Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding Class II Medical Device Functionality and PET-CT Capabilities

SAN FRANCISCO, Oct. 30, 2025 /PRNewswire/ -- Sirona Medical today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking ...
MarketWatch

Rocket Pharmaceuticals Shares Surge after FDA Accepts Drug Application Resubmission

Shares of Rocket Pharmaceuticals surged after the Food and Drug Administration accepted its resubmitted application for its Kresladi drug to treat severe Leukocyte Adhesion Deficiency-I, a rare ...
Hosted on MSN

FDA Issues Class II Risk Warning for Fruit Cocktail Recall in 27 States

A wide-reaching recall of fruit products has been initiated across 27 states due to the risk of lead contamination. The U.S. Food and Drug Administration (FDA) issued a warning that includes a range ...
The Bakersfield Californian

Tr1X Announces FDA Clearance of IND Application for TRX319, a First-in-Class Allogeneic CAR-Tr1 ...

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Seeking Alpha

Rocket Pharmaceuticals withdraws review application to FDA for RP-L102

Rocket Pharmaceuticals (NASDAQ:RCKT) reported that it has voluntarily withdrawn its biologics marketing application to the U.S. FDA for mozafancogene autotemcel or RP-L102, an investigational gene ...
Reuters

FDA panel to weigh in on AI mental health devices

Sept 11 (Reuters) - The U.S. Food and Drug Administration will hold an advisory panel meeting in November to examine the fast-emerging class of AI-enabled digital mental health devices. The agency's ...
JD Supra

FDA Publishes Complete Response Letters for Unapproved Drug Applications

On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination ...
Cure Today

FDA Approved Camcevi ETM New Drug Application for Prostate Cancer

Camcevi ETM, a long-acting injectable, is FDA-approved for advanced prostate cancer, showing 97.9% efficacy in testosterone suppression in a phase 3 study. Common side effects include hot flushing and ...
Morningstar

AliveDx registers MosaiQ®, its Instrument for Multiplex Testing of Autoimmune Diseases, Allergies and Beyond, as a Class II Exempt Device with the U.S. Food and Drug ...

The MosaiQ solution is a next-generation IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex ...
FierceBiotech

Stealth Bio submits third FDA application for rare disease candidate

After an FDA rejection in May, Stealth BioTherapeutics has resubmitted a new drug application for its investigational treatment designed to treat an ultra-rare genetic disease. This is the biotech’s ...
Austin American-Statesman

FDA recalls NuNaturals sweeteners due to mislabeling. See what products received Class II warning

A sugar-free sweetener received the second-highest warning from the U.S. Food and Drug Administration. NuNaturals Inc. was issued a Class II recall for two of its products. On July 14, NuNaturals ...