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FDA releases the 12-page form FDA-483 with six observations from an inspection at Indias Hetero Labs Unit 9 API manufacturing faci...[ Price : $8.95]
FDA grants Akamis Bio a fast-track designation to NG-350A for treating mismatch repair-proficient locally advanced rectal cancer.[ Price : $8.95]
Oncologist John Burke analyzes the positive and potentially negative impacts of FDAs new guidance on overall survival as an endpoi...[ Price : $8.95]
FDA approves a bioLytical Laboratories PMA for the INSTI HIV Self Test, an at-home HIV test that delivers results in 60 seconds or...[ Price : $8.95]
FDA warns New York, NY-based Allovate Therapeutics that it is illegally marketing its Allerdent toothpaste that is an unapproved n...[ Price : $8.95]
FDA warns Nesconset, NY-based LifeVac that it is illegally marketing and distributing an airway clearance device.[ Price : $8.95]
FDA accepts for review a Cingulate NDA for CTx-1301 (dexmethylphenidate), a once-daily stimulant designed to treat attention-defic...[ Price : $8.95]
An Astellas Phase 2 study evaluating zolbetuximab in combination with standard chemotherapy for metastatic pancreatic cancer fails...