Findings from HERTHENA-Lung02 showed that the key secondary endpoint of overall survival did not meet statistical significance.

The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for ...

Merck (MRK) stock falls as the company withdraws U.S. marketing application for lung cancer therapy HER3-DXd developed with ...

Candel Therapeutics, Inc. (NASDAQ:CADL) has secured FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its ...

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has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing ...

The BLA seeking accelerated approval for patritumab deruxtecan in previously treated, locally advanced EGFR-mutated NSCLC in ...

After Merck paid a hefty sum to co-develop and co-commercialize HER3-DXd, the drug has suffered notable setbacks in ...

Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter ...

The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...

The FDA issued Thursday recommendations for replacing color additives in approved or marketed drug products, reminding the ...

OCU410ST has received a rare pediatric disease designation for ABCA4-associated retinopathies, potentially allowing Ocugen to ...