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Biologics

Upcoming CBER Changes Explained

Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in INDs and BLAs submitte...

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Human Drugs

Ideaya Bio Gets Fast Track for IDE161

FDA grants Ideaya Biosciences a Fast Track designation for IDE161 for treating certain adult patients having advanced or metastatic ovarian cancer wit...

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Human Drugs

Ionis Plans NDA for Triglyceride Drug

Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with familial chylomicro...

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Medical Devices

Trax Compression Bone Screws Cleared

FDA clears a Trax Surgical 510(k) to market its Trax Compression Screw System that offers a wide range of bone screws for osteotomy, fixation, fusion,...

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Human Drugs

Drug Use Software Guidance Analyzed by Attorneys

Foley Hoag attorneys analyze the questions about promotional labeling raised by a recent FDA draft guidance on prescription drug use related software.

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Human Drugs

Novartis Touts Positive Lutathera Phase 3 Data

Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondary endpoint of object...

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Human Drugs

FDA Reviewers Dismiss ALS Therapy Benefit

FDA reviewers say clinical data submitted in a BrainStorm Cell Therapeutics BLA for Lou Gehrigs Disease treatment NurOwn do not demonstrate efficacy a...

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Federal Register

Calcipotriene ANDA Withdrawal Corrected

Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.

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Medical Devices

FDA Clears Profound Medical Ablation Module

FDA clears a Profound Medical 510(k) for the companys Thermal Boost module for use in conjunction with its Tulsa-Pro, which permits surgeons to ablate...

Medical Devices

Exactech Activit-E Polyethylene Cleared

FDA clears an Exactech 510(k) for its Activit-E polyethylene for the Vantage Total Ankle System.