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Schrdinger Nixes Leukemia Drug After 2 Deaths

[ Price : $8.95]

After two deaths in trial, Schrdinger decides to stop developing SGR-2921, its CDC7 inhibitor being evaluated in a Phase 1 dose-es...

Halda Gets Fast Track for Prostate Cancer Drug

[ Price : $8.95]

FDA grants Halda Therapeutics a Fast Track designation for HLD-0915 and its use for treating metastatic castration-resistant prost...

Restrictions Asked for Ozempic ANDAs

[ Price : $8.95]

A Foley & Lardner client petitions FDA not to approve ANDAs citing Ozempic as the reference-listed drug unless restrictions sought...

CDER Equal Voice MAPP

[ Price : $8.95]

FDA publishes a CDER Manual of Policies and Procedures outlining the Centers Equal Voice process for ensuring that all staff are h...

HHS Revives Task Force on Safer Child Vaccines

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HHS revives a task force on safer childhood vaccines, a federal panel created by Congress to improve child vaccine safety, quality...

Thoratec Recalls HeartMate Mobile AC Power Cord

[ Price : $8.95]

Thoratec recalls (Class 1) its HeartMate Mobile Power Unit AC power cord due to unintended power disconnections.

Texas Sues Lilly Over Illegal Kickbacks

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Texas attorney general Ken Paxton sues Eli Lilly for violating state law by giving illegal kickbacks to healthcare providers as in...

2 Charged for Misbranded Imported Drugs

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The Justice Department says two men have been charged and one has agreed to plead guilty in a case involving the importation, repa...

Ocular Therapeutix Gets FDA Trial Protocol Agreement

[ Price : $8.95]

Ocular Therapeutix receives FDA agreement on a Special Protocol Assessment for evaluating Axpaxli in the treatment of non-prolifer...

New Methods for Pediatric Drug Safety Workshop

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FDA announces a 12/5 Public Workshop on Pediatric Drug Development Safety and New Approach Methodologies.