as well as a thorough English language literature search from 2020 to July 2023 across multiple databases (PubMed, MEDLINE, Springer Nature, Google Scholar and Cochrane) for various keywords (alone and in combination) such as "FDA approved" OR "recent advances in therapy" OR "recent drugs" OR...
Nearly one third of drugs newly approved by the US Food and Drug Administration (FDA) are affected by safety issues that were not known at the time of approval, a study has shown. Biologic and psychiatric drugs, as well as those that received accelerated approval or were approved within 60 ...
This study applies the ‘Flexible-Acceptor’ variant of the General Solubility Equation, GSE(Φ,B), to the prediction of the aqueous intrinsic solubility, log10 S0, of FDA recently-approved (2016–2020) ‘small-molecule’ new molecular entities (NMEs). The novel equation had been shown to pr...
In October, the US Food and Drug Administration (FDA) approved two new drugs,nintedanib(Ofev®, Boehringer Ingelheim) andpirfenidone(Esbriet®, InterMune), to help manage this condition. Medscape Advisory Board member for Pulmonary Medicine, Steven Nathan, MD, was a principal investigator in s...
Nikhil Palekar, MD:Well firstly, thank you for having me today. I really appreciate it, and this is definitely a moment in history. It’s the first medication that has been approved by FDA that has shown some meaningful clinical benefit to patients...
1. FDA approves quizartinib for newly diagnosed acute myeloid leukemia. News release. July 20, 2023. Accessed July 20, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia 2. Erba HP, Monetesinos P, Kim HJ, et al. Qui...
The FDA has approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnos
symptoms allowing clinicians to provide an individually tailored care for PD patients. Here, we review the existing and emerging interventions for PD with focus on newly approved and investigational drugs for motor symptoms, motor fluctuations, dyskinesia, and balance and gait dysfunction....
Scientists, and the FDA's advisory board, have been concerned about coverage for the drug. In the case of CAR-T, insurer UnitedHealthcare requested that CMS issue a national coverage decision to avoid the potential for variance in local decisions. The complexity of the th...
WE HEREIN describe two new investigational drugs, cytomegalovirus immune globulin and trimetrexate glucuronate, that physicians may obtain under treatment protocols for certain patients with the serious or life-threatening conditions for which the drugs are indicated. The drugs have been approved for earl...