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Tag: FDA

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Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition

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Aptar Pharma, a global leader in drug delivery and active material science solutions and services, announced its acquisition of the clinical trial materials manufacturing...

Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

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Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced on June 5 2025,  that LUMRYZTM has been granted Orphan...
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Building the Right Team and Resource Model to Support Quality System and Validation Activities

Drug Development 0
Since life science quality and validation projects can vary...

Merck and Blackstone Enter R&D Funding Agreement for sac-TMT

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Merck, recognized as MSD outside the U.S. and Canada,...

FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

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Johnson & Johnson said the U.S. Food and Drug...

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

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UCB, a leading global biopharmaceutical company, has announced that...

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