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FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies develop...[ Price : $8.95]
Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an e...[ Price : $8.95]
FDA accepts for priority review a Chiesi NDA for idebenone and its use in treating Leber hereditary optic neuropathy.[ Price : $8.95]
FDA escalates medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in o...[ Price : $8.95]
Rep. Frank Pallone Jr. (D-NJ) sharply criticizes Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of underm...[ Price : $8.95]
FDA approves Medtronics Altaviva implantable tibial neuromodulation device for treating urge urinary incontinence.[ Price : $8.95]
FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain sel...[ Price : $8.95]
FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatr...