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FDA OKs Cross Vetpharm ANADA

[ Price : $8.95]

Federal Register Final rule: FDA approves a Cross Vetpharm ANADA for using tylosin tartrate in chickens, turkeys, swine, and honey...

Info on Investigational Animal Drugs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on new animal drugs for investigational uses to the Offi...

4 Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that four drug products, loxitane, zofran and dextrose injection, and fortovase, were not ...

Panels to Discuss Oral Contraceptives and Blood Clot Risks

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Federal Register Notice: FDAs Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Co...

Novartis Afinitor Phase 3 Trial Meets Primary Endpoint

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Novartis says a Phase 3 clinical study of its Afinitor tablets in patients with non-cancerous kidney tumors associated with tubero...

FDA OKs Remicade for Pediatric Ulcerative Colitis

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FDA approves an expanded indication for Janssen Biotech''s Remicade (infliximab) for treating moderately to severely active ulcera...

Soliris New Indication for Rare Blood Disease

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FDA approves an Alexion Pharmaceuticals BLA for Soliris (eculizumab) for treating all pediatric and adult patients with atypical h...

FDA, Industry Reach Agreement on Biosimilar Fee Goals

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FDA and industry stakeholders reach tentative agreement on proposed performance goals for a 351(k) biosimilars user fee program.

Guidance on Reproductive/Developmental Toxicities

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Federal Register Notice: FDA releases a guidance on integrating study results to assess concerns for reproductive and developmenta...

Aeolus Seeks Orphan Status for Radiation-exposure Drug

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Aeolus Pharmaceuticals submits an orphan drug application with FDA for AEOL 10150 for treating delayed effects of acute radiation ...