The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...
The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.
Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to ...
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending ...
MNV-201 is Minovia’s second generation mitochondrial cell therapy product composed of autologous hematopoietic stem cells ...
The U.S. Food and Drug Administration has once again declined to approve Aldeyra Therapeutics treatment for dry eye disease, ...
Received positive feedback on New Drug Application submission via the 505(b)(2) pathway-Company leveraging existing human pharmacokinetic data ...
Epicrispr Biotechnologies Announces FDA Clearance of IND Application for EPI-321, A First-in-Class Epigenetic Therapy for ...
The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish ...
EVM14 received FDA clearance for clinical trials, marking Everest Medicines’ first in-house developed therapeutic to reach ...
The FDA is requesting additional data demonstrating the effectiveness of reproxalap on treating ocular symptoms of dry eye. The Food and Drug Administration (FDA) has again issued a Complete ...
The U.S. Supreme Court on Wednesday largely backed the U.S. Food and Drug Administration's refusal to let two e-cigarette ...
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