Business Wire25d
Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma
A previously published subgroup analysis from the Phase 3 FOCUS trial demonstrated no significant differences in objective response rate, progression-free survival, or overall survival between ...
Food Safety News22h
FDA employees now lack the tools to do their jobs
Many critical functions of the food division of the Food and Drug Administration have been drastically slowed or entirely stopped since late ...
Wall Street Journal4d
DexCom Gets FDA Warning Letter After Inspections of Facilities
DexCom DXCM-2.10%decrease; red down pointing triangle received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is ...
Business Insider8d
BioXcel announces FDA closed inspection of TRANQUILITY II Phase 3 trial site
BioXcel Therapeutics (BTAI) announced that the U.S. Food and Drug Administration has concluded that the inspection of a single site in its TRANQUILITY II Phase 3 trial is closed under 21 C.F.R.20. ...
The Hindu19d
Aurobindo Pharma arm’s New Jersey warehouse gets OAI status after U.S. FDA inspection
The U.S. Food and Drug Administration (U.S. FDA) has classified a warehouse of Aurobindo Pharma subsidiary in New Jersey, U.S. as Official Action Indicated (OAI) after an inspection it conducted.
Morningstar4d
DexCom Gets FDA Warning Letter After Inspections of Facilities
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...
Pharmabiz19d
Orchid Pharma's Alathur API facility successfully completes US FDA inspection
announced the successful completion of a surprise US Food and Drug Administration (FDA) inspection at its active pharmaceutical ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The ...
FiercePharma13d
FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
FiercePharma28d
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
Nuowei received its write-up after an FDA inspection of its facility in Xuancheng, China, last September. Innovation Pharmaceutical’s reprimand followed a record request for its Chengdu plant by ...
India Infoline23d
Zydus Passes US FDA Inspection at Ambernath Facility with Zero Observations
Zydus Lifesciences Ltd received the “No Observation” from US Food and Drug Administration in its recently concluded surveillance inspection of its API (Active Pharmaceutical Ingredients ...
Staten Island Advance5d
FDA announces recall on popular salad kits sold in several states
The U.S. Food and Drug Administration has announced a recall on popular salad kits sold in several states due to undeclared allergens. Little Leaf Farms is recalling a specific lot code of its ...