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Fast Track Given to Aridis Monoclonal Antibody

[ Price : $8.95]

FDA grants Aridis Pharmaceuticals a fast track designation for AR-301, a fully human anti-Staphylococcal alpha-toxin IgG1 monoclon...

MediciNovas Tipelukast Gets Fast Track forFibrosis

[ Price : $8.95]

FDA grants fast track designation to MediciNova for its MN-001 (tipelukast) for treating patients with idiopathic pulmonary fibros...

FDA Accepts Theravance sNDA for Vibativ

[ Price : $8.95]

FDA accepts for review a Theravance Biopharma supplemental NDA for Vibativ (telavancin) seeking to expand the current label to inc...

Novo Nordisk/MIT Collaborate on Peptide Delivery Devices

[ Price : $8.95]

Novo Nordisk announce a research collaboration with Langer Laboratory at the Massachusetts Institute of Technology to develop the ...

FDA Fast Track Given to BioCancell Bladder Cancer Drug

[ Price : $8.95]

FDA grants BioCancell a fast track designation for BC-819 and its use in treating bladder cancer patients.

FDA Strengthens Canagliflozin Warnings

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FDA revises labeling for Janssens diabetes drug Invokana (canaglifozin) to explain an increased risk of bone fracture and reduced ...

FDA Accepts Teva sNDA for Pediatric ProAir RespiClick

[ Price : $8.95]

FDA accepts for review a Teva Pharmaceutical Industries supplemental NDA for ProAir RespiClick (albuterol sulfate) Inhalation Powd...

Wellstat Therapeutics Uridine Triacetate NDA Accepted

[ Price : $8.95]

FDA accepts for review a Wellstat Therapeutics NDA for its investigational drug uridine triacetate, indicated as an antidote for p...

OMB OKs Info on Investigational Animal Drugs

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Federal Register Notice: The Office of Management and Budget approves a collection of information on new animal drugs for investig...

ICH Guidance on Elemental Impurities for Drugs

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Federal Register Notice: FDA releases an ICH guidance: Q3D Elemental Impurities for drug products.