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Tag: America

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Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Food and Drug Administration (FDA) requested an additional clinical study as part of...

FDA Approves Dyanavel XR

Tris Pharma Receives FDA Approval of Dyanavel XR (amphetamine) Once-Daily Liquid for ADHD in Children ("Tris") announced that the U.S. Food and Drug Administration...

Drugs Used in Cancer, Arthritis May Help Fight Hair Loss

one approved for use in arthritis and the other approved for cancer -- may also hold potential for boosting hair growth, new animal research...

Allergan to Present New Data for VIBERZI™ (eluxadoline) at the American College of Gastroenterology 2015 Annual Scientific Meeting

Allergan plc today announced that three data posters/presentations for eluxadoline will be presented during the American College of Gastroenterology 2015 Annual Scientific Meeting in...

FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC)...

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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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