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Tag: FDA

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US FDA Approves Breast Cancer Therapy Inluriyo by Eli Lilly

Eli Lilly and Company has received U.S. Food and Drug Administration (FDA) approval for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist....

US FDA to Approve Leucovorin for Cerebral Folate Deficiency

The U.S. Food and Drug Administration (FDA) has started the process to approve leucovorin calcium tablets as a treatment for patients with cerebral folate...

FDA Grant Approval for Opzelura Cream for Pediatric Eczema

The U.S. Food and Drug Administration has granted approval to Incyte’s eczema cream, Opzelura, for use in children aged 2 to 11 years, the...

Amneal Secures FDA Approval for Sodium Oxybate Oral Solution

Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s sodium oxybate oral solution 500...

US FDA Tightens Oversight on Misleading Drug Advertising

The U.S. Food and Drug Administration (FDA) announced that it will issue approximately 100 cease-and-desist enforcement notices alongside thousands of warning letters directed at...

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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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