Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide ...
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
One recent example is the FDA accelerated approval of Vijoice® (alpelisib ... of data in the health technology assessment (HTA) process to support reimbursement discussions.
The most common approval process for clinical trials using unapproved ... India are required to obtain written permission from the Drug Controller General of India (DCGI). The DCGI is part of ...
Disc Medicine has finalized the design of the confirmatory trial for its rare blood disorder drug candidate, adding a ...
An FDA advisory committee may have ruled in elamipretide’s favor back in October, but it looks like Stealth BioTherapeutics ...
The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...
The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. Volunteers were ...
Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA,” published in the January 2025 issue of ...
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression ...
The Food and Drug Administration (FDA) approved Johnson & Johnson's ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression. Spravato, approved as a ...
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