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Joint FDA Panel Votes Down Bladder Cancer Drug

[ Price : $8.95]

An FDA joint advisory committee meeting votes 6 to 18 to not recommend approval for a Telesta Therapeutics BLA for Mycobacterium p...

Glaukos Files IND for Travoprost Intraocular Implant

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Glaukos Corp. files an IND seeking authorization to study its Travoprost Intraocular Implant with the iDose delivery system to red...

44 Freshmen Members in Congress Urge Device Tax Repeal

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U.S. congresswoman Elise Stefanik (R-NY) leads a bipartisan group of 44 freshmen members of Congress in sending a letter to House ...

FDA Wants More Makena Info

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FDA issues a complete response letter seeking more information about Amags application for a single-dose vial of its Makena.

Preemption Defense Alive and Well: Attorneys

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Two Covington & Burling attorneys say recent court decisions and appeals show that branded drug manufacturers are still making goo...

Shuren Testified Falsely on Morcellators: Activist

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Anti-morcellator activist Hooman Noorchashm charges that CDRH director Jeffrey Shuren either experienced a critical memory lapse o...

Too Much Being Made of Biosimilar Interchangeability: Woodcock

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CDER director Janet Woodcock says too much is being made of biosimilar interchangeability and pharmacy substitution as FDA moves t...

Lilly, Merck Extend Combination Drug Pact for Lung Cancer

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Eli Lilly and Merck extend an existing collaboration to evaluate the combination of Lillys Alimta and Mercks Keytruda in a pivotal...

FTC Wants Effexor Court Ruling Reversed

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The Federal Trade Commission asks an appeals court to reverse a lower court ruling that a Wyeth and Teva Effexor reverse-payment a...

FDA Releases 3 PMR/PMC Backlog Reports

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FDA posts its fifth, sixth and seventh reports on backlogs in postmarketing reports and commitments.