News

The Manila Times18m
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
NextCure gains global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights; Phase 1 clinical ...
FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews
WEDNESDAY, June 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) says it plans to use artificial ...
US FDA extends review of KalVista's swelling disorder drug due to heavy workload
The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...
Reuters11d
U.S. Food and Drug Administration
US FDA pauses Gilead trials testing experimental HIV pill combination The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV ...
Business Wire4d
U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer
Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the ...
Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA (ustekinumab-stba), expanding dosing options for pediatric patients
Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or ...
Food Safety News7h
FDA warns seafood processors in France and Nicaragua about HACCP violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
At Least 1.7 Million Eggs Have Been Recalled Across the U.S. — Here Are the States Affected
The U.S. Food and Drug Administration (FDA) has issued a recall of millions of eggs from the August Egg Company that had the ...
F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’
With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...
US FDA puts on hold Rein Therapeutics' lung disease drug trial
Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...