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Avadel sues FDA over the agencys decision to require a patent statement for the companys Lumryz NDA.[ Price : $8.95]
A Stat News opinion column argues the need for FDA and those working on synthetic cell therapies to open talks on an appropriate r...[ Price : $8.95]
FDA accepts a Biogen NDA for tofersen to treat a rare form of ALS and grants it priority review.[ Price : $8.95]
FDA grants a Taiho petition restricting generic forms of its Lonsurf cancer drug.[ Price : $8.95]
Researchers say FDA needs to strengthen enforcement against dietary supplements that contain prohibited ingredients.[ Price : $8.95]
FDA clears a Northeast Scientific 510(k) for reprocessing Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, ...[ Price : $8.95]
FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation ...[ Price : $8.95]
Two drug companies comment on an FDA draft guidance on antibacterial therapies.