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Alert on Medtronic DLP Left Heart Vent Catheters

[ Price : $8.95]

FDA issues an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Hea...

Sickle Cell Drug Misses Phase 3 Endpoint: Pfizer

[ Price : $8.95]

A Phase 3 study of Pfizers investigational sickle cell disease drug inclacumab fails to meet the primary endpoint.

BEAM-101 Gets Advanced Therapy Designation

[ Price : $8.95]

FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-101, an investigational gene-edited cel...

Group Pushes MDMA-Assisted Therapy for PTSD

[ Price : $8.95]

The Multidisciplinary Association for Psychedelic Studies calls on HHS and FDA to quickly approve its NDA for MDMA-assisted therap...

Trump Orders Strategic Reserve of APIs

[ Price : $8.95]

President Trump issues an Executive Order requiring HHS to obtain critical drug active pharmaceutical ingredients to be stored in ...

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

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

CDER Equal Voice MAPP

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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...