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Luminex Files 510(k) for Respiratory Pathogen Panel

[ Price : $8.95]

Luminex Corp. files a 510(k) application for the NxTAG Respiratory Pathogen Panel that can detect 21 respiratory pathogens in a si...

Boehringer/Lilly Diabetes Combination Drug Approved

[ Price : $8.95]

FDA approves a Boehringer Ingelheim and Eli Lillys Synjardy (empagliflozin and metformin hydrochloride) tablets for treating adult...

Suggestions to Improve DTC Research on Aging

[ Price : $8.95]

AbbVie and Lilly give FDA suggestions on ways to improve a proposed research project on how hearing loss associated with aging aff...

FDA Enforcement Discretion Doesnt Preempt Suit: Court

[ Price : $8.95]

A Washington Legal Foundation working paper says a recent appeals court decision risks allowing state law to undermine a Congressi...

Support for FDA Move on Endoscope Contamination

[ Price : $8.95]

Stakeholders voice support for an FDA draft guidance on mitigating the risk of cross-contamination in flexible gastrointestinal en...

FDA Recognizes RiduZone as a New Dietary Aid

[ Price : $8.95]

NutriForward says FDA has recognized its RiduZone as a new dietary supplement that supports healthy weight, appetite, body-fat com...

CBER Guidance on Gene Therapy Shedding Studies

[ Price : $8.95]

CBER posts a guidance on Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy (VBGT) and Oncolytic Pro...

Split Decision in Plavix Whistleblower Case

[ Price : $8.95]

Attorneys Jaime Jones and Brenna Jenny say that a New Jersey federal court dismissed many allegations brought by a whistleblower a...

FDA Approval Process Hurts Device Innovation: Study

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Harvard Business School professor Ariel Stern says that the FDA medical device approval process slows development of innovative ne...

FDA Priority Review for Sarepta Duchenne NDA

[ Price : $8.95]

FDA accepts for review a Sarepta Therapeutics NDA for eteplirsen for treating Duchenne muscular dystrophy amenable to exon 51 skip...