Monogram submits formal response to FDA Additional Information Request
Monogram Technologies provided an update regarding its 510(k) premarket filing submission to the U.S. Food and Drug Administration for the ...
Regeneron announces FDA accepted for review BLA for odronextamab
Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for review the resubmission of the ...
Adcendo ApS Announces U.S. FDA Clearance of IND Application for Phase I Tiffany-01 Trial of ADCE-T02
Adcendo, a biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, today announced that the U.S. Food & Drug Administration (FDA) has ...
manilatimes16h
FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food ...
FDA delays when a final rule on what foods can be labeled as ‘healthy’ goes into effect
The FDA's new standards for foods before they can be labeled as "healthy" on their packaging will go into effect about two months later than planned.
Telix Pharmaceuticals: FDA Accepts BLA for TLX250-CDx (Zircaix) for Kidney Cancer Imaging, Grants Priority Review
Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration ...
A little-known Chinese company made a drug that beat the world’s biggest-selling medicine
China’s DeepSeek shocked the world by delivering unexpected innovation at an unbelievable price. But this disruptive trend isn’t confined to Big Tech: It has been quietly happening in the ...
RESPIREE SECURES SINGAPORE HSA CLEARANCE FOR PEDIATRIC EXPANSION OF CARDIO-RESPIRATORY WEARABLE AND FOR ITS NEW EHR STREAMLINED PLATFORM
AI/ML health tech startup Respiree has received clearance from the Health Sciences Authority (HSA) to extend its RS001 cardio-respiratory wearable to ...
Eli Lilly plans at least $27 billion in new U.S. manufacturing investments
It comes as companies work to build goodwill with Trump, who has emphasized reshoring manufacturing to the U.S. and reducing ...
Quality Assurance23h
QA Exclusive: Food Safety Leaders React to Jim Jones’ Departure, FDA Layoffs
Jim Jones’ resignation as deputy commissioner for human foods at the U.S. Food and Drug Administration following the Trump ...
Facebook and Instagram publish graphic porn ads disguised as fake make-up tutorials
Hardcore pornographic videos have been disguised as make-up tutorials on Facebook and Instagram, an ABC NEWS Verify ...