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FDA Launches Elsa AI Tool for Efficiencies

[ Price : $8.95]

FDA launches a generative Artificial Intelligence tool called Elsa that is designed to help employees from scientific reviewers t...

Guide on Bioequivalence for Immediate-Release Drugs

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FDA releases a draft guidance entitled M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Bio...

Aurolife NC Drug Plant Hit With Form-483

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FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited s...

Group Seeks Warnings on Nuvigil, Provigil

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Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy because ...

Drug Firms Agree to Pay $51 Million in Pay-to-Delay Suit

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AstraZeneca and Handa Pharmaceuticals agree to pay $51.4 million to resolve allegations they participated in a pay-for-delay schem...

Breakthrough Status for Artificial Heart

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FDA grants BiVACOR a breakthrough device designation for its titanium Total Artificial Heart.

MAHA Report Questioned on Nonexistent Science

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Critics call out HHS secretary Robert F. Kennedy Jr.s recent Make America Healthy Again report for citing allegedly nonexistent sc...

FDA Proposes Accelerated Approval Pathway for Stealth NDA

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FDA issues Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek acce...

Alcon Dry Eye Drug Tryptyr Approved

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FDA approves an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disea...

HHS Nixes Moderna Bird Flu Vaccine Funding

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HHS terminates a late-stage grant award to Moderna for developing a vaccine candidate targeting the H5 bird flu.