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Human Drugs

Tarrex Biopharma IND for Colorectal Cancer Therapy

Tarrex Biopharma files an IND for TX803, a novel treatment for colorectal cancer.

FDA General

Trumps FDA External Affairs Chief Named

FDA acting commissioner Stephen Ostroff names longtime Republican operative Jack Kalavritinos as the Trump Administrations FDA associate commissioner ...

Biologics

FDA Gives Humacyte a Regenerative Medicine Designation

FDA grants Humacyte a Regenerative Medicine Advanced Therapy designation for the companys investigational human acellular vessel Humacyl.

Medical Devices

FDA Approves Allergans Juvderm Vollure XC

FDA approves Allergans Juvderm Vollure XC gel for correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults aged 21...

Medical Devices

FDA Clears Trovita Safe-T Feed Device

FDA clears a Trovita Health Science 510(k) for its Safe-T Feed device for administering tube feeding formulas.

Human Drugs

FDA Sees Rise in GMP Violations at Supplement Makers

A report by ConsumerLab.com shows that FDA inspections of dietary supplement makers in 2016 saw an increase in GMP violations.

Human Drugs

4 Former FDA Heads Criticize Drug Importation

Four former FDA commissioners urge Congress to not allow the importation of drugs not approved by the agency as a means to make lower-cost therapies a...

Human Drugs

FDA Safety Alert on Abbott Absorb Vascular Scaffold

An FDA safety alert advises health care providers that Abbott Vasculars Absorb GT1 Bioresorbable Vascular Scaffold (BVS) has seen an increased rate of...

Human Drugs

Esperion Therapeutics Plans NDA for Cholesterol Lowering Agent

Esperion Therapeutics says it is planning to file in mid-2019 an NDA for bempedoic acid based on FDA confirmation that the products development progra...

Human Drugs

Array Bio Pulls NDA Filling Over Clinical Benefit Concerns

Array BioPharma withdraws its recent NDA for binimetinib monotherapy for treating NRAS-mutant melanoma, a rare, mutationally-driven subset of skin can...