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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alkermes Vumerity (diroxime...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorization issued to Gilead Sciences for Veklury (remdesivir) for treati...[ Price : $8.95]
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, ...