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Novo Nordisk/MIT Collaborate on Peptide Delivery Devices

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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

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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

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

Wellstat Therapeutics Uridine Triacetate NDA Accepted

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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.

Guidance on Distributor Labeling for Animal Drugs

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Federal Register Notice: FDA releases a draft guidance: Distributor Labeling for New Animal Drugs.

Workshop Slated on Osteoporosis Drug Development

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Federal Register Notice: CDER plans a public workshop 11/4: Osteoporosis Drug Development: Moving Forward.

New York AG Acts Against 13 Supplement Makers

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New York attorney general Eric Schneiderman sends letters to 13 dietary supplement manufacturers asking that they stop marketing a...