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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals Onp...[ Price : $8.95]
FDA issues Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER...[ Price : $8.95]
The U.S. Supreme court decides to not hear a closely watched appeal of a lower courts ruling in a so-called skinny label case won ...[ Price : $8.95]
FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray...[ Price : $8.95]
Federal Register notice: FDA publishes its final decision rendered last month to withdraw approval of Covis Pharma Groups Makena (...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Recommendations for Evaluating Donor Eligibility Using Indi...[ Price : $8.95]
Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or e...[ Price : $8.95]
FDA grants Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer.