New FDA Rules for TV Drug Ads: Simpler Language and No Distractions
FDA's new rules aim to make drug ads clearer and more transparent, addressing long-standing concerns about risk information ...
News Medical2d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions.
Business Insider2d
ClearPoint Neuro announces SmartFlow Neuro Cannula FDA authorization
ClearPoint Neuro (CLPT) “announced the U.S. Food and Drug Administration has granted marketing authorization for the SmartFlow Neuro Cannula using the De Novo pathway. The SmartFlow Neuro ...
Business Insider4d
Johnson & Johnson: FDA grants nipocalimab Breakthrough Therapy designation
Johnson & Johnson announced that the U.S. Food and Drug Administration has granted nipocalimab Breakthrough Therapy designation for the treatment of adults living with moderate-to-severe Sjogren ...
Morningstar3d
GE HealthCare Gets FDA Approval For Head-Only MRI Scanner
The Chicago-based medical technology company said the MRI device, called Signa Magnus, had received 510(k) clearance by the U.S. Food and Drug Administration. That approval pathway is for devices ...
Food Safety News2d
Patient count in McDonald’s E. coli outbreak tops 100; FDA continues investigation
The patient count now stands at 104. The Food and Drug Administration and the Centers for Disease Control and Prevention are continuing to investigate the outbreak. Of 98 patients interviewed ...
NINER Pharmaceutical Strengthens Global Presence with Strategic IV Fluid Supply Initiative for the U.S. and Latin American Markets
NINER Pharmaceutical, a leading name in the pharmaceutical sector, announces its strategic expansion into the U.S. and Latin American markets to address critical shortages of IV fluids. Responding to ...
Kraft Heinz must face Mac & Cheese lawsuit, judge rules
In a decision on Wednesday, U.S. District Judge Mary Rowland said the Illinois, California and New York consumers leading the lawsuit plausibly alleged that Kraft Mac & Cheese contained a synthetic ...
Morningstar5d
Novavax to Move Forward With Covid-19, Influenza Vaccine After FDA Lifts Clinical Hold
The Gaithersburg, Md., vaccine developer said Monday that the U.S. Food and Drug Administration had removed the clinical hold on its investigational new drug application for its combined vaccine ...
Nuvectis Pharma CEO Says Increased Dose Intensity Needed To Drive More Efficacy From Ovarian Cancer Lead Drug
Nuvectis Pharma CEO Says Increased Dose Intensity Needed To Drive More Efficacy From Ovarian Cancer Lead Drug Nuvectis Pharma, Inc. (NASDAQ: NVCT) stock is trading lower after the company reported ...
Roll Call2d
At packed UFO hearing, calls for transparency ring loud
And it convinced him, as well as other panelists who testified Wednesday, of a potential “constitutional crisis” and a fundamental lack of transparency from the executive branch, the military ...