Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

Immunovant's batoclimab showed positive Phase 3 results in MG but won't be pursued for approval as the company shifts focus ...

Q4 2024 Management View CEO Eef Schimmelpennink highlighted 2024 as a transformative year, marked by significant milestones, including the completion of the Phase 3 CLARITY study, submission and ...

The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...

The Health and Human Services Secretary directed the FDA to consider eliminating a pathway that allowed companies to ...

The FDA has approved Keytruda plus chemotherapy in HER2+ gastric or GEJ adenocarcinoma with PD-L1–positive expression, based on KEYNOTE-811 data.

A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...

FDA accepts Capricor's Biologics License Application for priority review, advancing deramiocel for DMD cardiomyopathy.

Regulatory and reimbursement pathways should consider indirect benefits in addition to direct health benefits when evaluating ...

On Monday, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Monogram Technologies Inc.’s (NASDAQ:MGRM ...

New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025Upon FDA approval, ...