The clearance of Redemplo for a rare genetic disorder marks Arrowhead’s transition, after two decades, into a ...
The U.S. Food and Drug Administration approved Arrowhead Pharmaceuticals' drug for a type of genetic disorder that causes ...
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...
The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles ...
Genmab's Epkinly receives traditional FDA approval for relapsed or refractory follicular lymphoma in combination and ...
The U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb) as the first interchangeable biosimilar to ...
BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...
One of the more competitive targets in lung cancer is a certain mutation that has eluded many available targeted therapies. A drug developed by Dizal Pharmaceutical has received FDA approval for ...
Clinical data must be strong enough to exclude regression to the mean.
Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...
Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...
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