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Tag: FDA

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US FDA Approves Bladder Cancer Treatment Inlexzo from J&J

The U.S. Food and Drug Administration has granted approval to Johnson & Johnson’s drug delivery system for a specific type of bladder cancer. The...

FDA Approves Recombinant VWF Treatment in Pediatric Patients

The US Food and Drug Administration (FDA) has expanded the indication for recombinant von Willebrand factor (VWF), marketed as Vonvendi, to include children with...

FDA Approves Eisai’s Leqembi IQLIK for Alzheimer’s Treatment

Eisai has achieved an important regulatory milestone as the FDA approves Leqembi IQLIK, strengthening the company’s long-term plans to expand the medicine’s use in...

FDA Approves Sanofi’s Wayrilz for Immune Thrombocytopenia

The US FDA approves Sanofi’s Wayrilz (rilzabrutinib) for use in adult patients with chronic or persistent immune thrombocytopenia (ITP) who did not respond adequately...

U.S. FDA Approves Ionis’ DAWNZERA for Hereditary Angioedema

Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval for DAWNZERA™ (donidalorsen). The treatment is approved for prophylaxis to...

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Building the Right Team and Resource Model to Support Quality System and Validation Activities

Since life science quality and validation projects can vary...

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

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

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

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

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

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

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