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Heidelberg Pharmas Myeloma Drug Gets Fast Track

[ Price : $8.95]

FDA grants Heidelberg Pharma a fast track designation for HDP-101 (pamlectabart tismanitin), the companys lead antibody drug conju...

Ventyxs Oral NLRP3 Inhibitor Shows Promise in Study

[ Price : $8.95]

Ventyx Biosciences reveals positive Phase 2 data for its oral NLRP3 inhibitor VTX3232 in patients with obesity and cardiovascular ...

GSKs Blenrep Approved for Market Reintroduction

[ Price : $8.95]

FDA approves a GSK BLA for Blenrep (belantamab mafodotin-blmf) in combination with bortezomib (Velcade) and dexamethasone for trea...

Q&A on Expanded Access to Investigational Drugs

[ Price : $8.95]

FDA publishes a guidance with its latest questions and answers on the implementation of regulations covering expanded access to in...

Tango Therapeutics Encouraging Cancer Drug Data

[ Price : $8.95]

Tango Therapeutics reports that new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy ...

FDA Blocking Drug Info Consumers Need: Report

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A ProPublica investigative report faults FDA for blocking information about foreign-made generic drugs that could help patients, d...

Office of New Drugs RTF MAPP

[ Price : $8.95]

The CDER Office of New Drugs publishes a MAPP on the regulatory basis for refusing to file an NDA, sNDA, BLA, or sBLA.

FDA Publishes Drug Filing Checklists to Avoid Delays

[ Price : $8.95]

FDA publishes the checklists used by CDER reviewers to determine if an NDA or BLA can be accepted for filing.

sBLA for PadcevKeytruda Combo in Bladder Cancer

[ Price : $8.95]

FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...

Fast Track for Myosin Glioblastoma Drug

[ Price : $8.95]

FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.