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FDA approves a Cumberland Pharmaceuticals supplemental NDA for a simplified dosing regimen of its Acetadote (N-acetylcysteine for ...[ Price : $8.95]
Merck says a Phase 3 KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza...[ Price : $8.95]
Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or ...[ Price : $8.95]
FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.[ Price : $8.95]
AbbVie announces positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as an early Parkinson's dise...[ Price : $8.95]
Chimerix plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3...[ Price : $8.95]
FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturin...[ Price : $8.95]
FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Biore...