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Biotronik Breakthrough Status for Freesolve Device

[ Price : $8.95]

FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable magnesium scaffold, intended for...

GSK Reports Favorable Jemperli Phase 3 Data

[ Price : $8.95]

GSK reports favorable overall survival and progression-free survival data in a Phase 3 trial involving Jemperli (dostarlimab) in a...

Eugia Inspection Results in 7-Item FDA 483

[ Price : $8.95]

A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.s Telangana, India sterile drug manufacturing facility results in a seven...

Bayers Aliqopa Withdrawn Over Failed Confirmation

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of Bayers NDA for Aliqopa (copanlisib) in response to a failed confirmatory tr...

Guidance on Generic Drug Controlled Correspondence

[ Price : $8.95]

FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.

Orchards Leukodystrophy Gene Therapy OKd

[ Price : $8.95]

FDA approves an Orchard Therapeutics BLA for Lenmeldy (atidarsagene autotemcel), a one-time, single-dose gene therapy indicated fo...

Sleepnet Recalls Sleep Apnea Masks

[ Price : $8.95]

Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices.

CDER Launches Inspections Web Page

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FDA launches a new Web page to highlight how it uses inspections to help ensure drug safety and quality.

More Info on Quality Manufacturing Maturity

[ Price : $8.95]

FDA provides additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturi...

Generic Drug Controlled Correspondence Guidance

[ Price : $8.95]

FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.