British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority ...

FDA prioritizes review of liso-cel, a groundbreaking CAR T-cell therapy for relapsed marginal zone lymphoma, promising ...

British drugmaker GSK said on Monday its supplemental new drug application for antibiotic drug gepotidacin has been accepted for priority review by the U.S. Food and Drug Administration for the oral ...

Epcoritamab shows promising results in treating relapsed follicular lymphoma, with FDA priority review for a groundbreaking ...

Epkinly with Rituxan and Revlimid, compared to Rituxan and Revlimid alone, reduced risk of progression or death by 79%.

Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set ...

The FDA accepted a supplemental application for Breyanzi to treat adults with relapsed or refractory marginal zone lymphoma ...

The promising results, along with a separate FDA decision, could signal a major expansion of the use of the two companies' ...

Kura Oncology missed GAAP revenue estimates in Q2 2025. Ziftomenib advanced to FDA Priority Review, hitting key clinical and regulatory milestones, with no product sales yet. Research and ...

At the 2025 EHA Congress, Dr. Harry Erba of Duke University presented Phase Ia/Ib data from the KOMET-007 trial testing ziftomenib at a 600-milligram once-daily dose plus intensive chemotherapy in ...

Treatments for acromegaly, edema, HSCT-associated thrombotic microangiopathy, multiple sclerosis, and spinal muscular atrophy are under review.

US FDA accepts for priority review Bristol Myers Squibb’s sBLA for Breyanzi to treat adult patients with relapsed or refractory MZL: Princeton, New Jersey Wednesday, August 6, 2 ...