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FDA Breakthrough for NRG1+ Cholangiocarcinoma Drug

[ Price : $8.95]

FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcino...

Inhibrx Posts Positive Phase 3 Results for Ozekibart

[ Price : $8.95]

Inhibrx Biosciences reports favorable data for treating chondrosarcoma with its antibody therapy ozekibart (INBRX-109).

Sumitomo Pharma Gets FDA-483 After Inspection

[ Price : $8.95]

FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.

FDA Payroll Glitch Delays Pay for Some Exempt Staff

[ Price : $8.95]

An FDA payroll system error causes a paycheck delay for some FDA employees who are designated to continue working during the ongoi...

Bayer Dual-Neurokinin Menopause Drug Approved

[ Price : $8.95]

FDA approves Bayers Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms associated with menopause.

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

[ Price : $8.95]

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.

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...