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Complete Response on Lillys Ulcerative Colitis Drug

[ Price : $8.95]

FDA sends Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis.

Revised Draft Guide on Transdermal Drug Adhesives

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance Assessing Adhesion With Transdermal and Topical Delivery Sys...

PTA Catheter Submission Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Peripheral Percutaneous Transluminal Angioplasty (PTA) and ...

High Court Issues 5-day Stay in Abortion Drug Case

[ Price : $8.95]

The Supreme Court grants a Department of Justice-requested temporary stay of a lower courts 4/7 order that would have restricted t...

GOP Reps Challenge Generics from Alert Firms

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Five House Republicans write FDA commissioner Robert Califf about agency safeguards in place when questionable foreign-made generi...

2nd Complete Response on Alvotech Humira Biosimilar

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FDA sends Alvotech a second complete response letter on its BLA for AVT02, a biosimilar candidate referencing AbbVies Humira (adal...

FDA Wants 2nd Study in Solgenix NDA

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Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received for its HyBryte (synthetic hyper...

Moximed Knee Shock Absorber Cleared

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FDA clears a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoart...

Lupin Hit with 13-page 483 at India Plant

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FDA posts a 13-page Form FDA-483 addressed to Lupin LTD. that cites significant GMP deficiencies from a 03/21-29 inspection.

ANDA Transdermal/Topical Delivery Systems Guide

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Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Tr...