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Mesoblast Refiling BLA for Remestemcel-L

[ Price : $8.95]

Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease ...

FDA Warns Against Topical OTC Analgesics

[ Price : $8.95]

FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain befo...

PARP Inhibitor Ovarian Cancer Indications Withdrawn

[ Price : $8.95]

Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advance...

Quantitative Medicine Center of Excellence Created

[ Price : $8.95]

CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform re...

4 Information Collections Approved by OMB

[ Price : $8.95]

FDA posts a notification about four information collections that have been approved by OMB.

Medline Recalls Kits/Tray Over Sterility

[ Price : $8.95]

Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chlorid...

J&Js Opsynvi OKd for Pulmonary Hypertension

[ Price : $8.95]

FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonar...

Regeneron Complete Response on Lymphoma BLA

[ Price : $8.95]

FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular ly...

FDA Again Seeks Ban on Shock Devices

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Following recent Congressional action giving FDA additional authorities, the agency is again proposing a rule to ban electrical st...

GAO Report Hits FDA on Investigator Retention

[ Price : $8.95]

A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and main...