Federal regulators have granted accelerated approval to a novel therapy for advanced melanoma—giving doctors another weapon ...

In combination with ZDd, Zenbexus received the agency’s decision following results from the Phase III EXCALIBER-RRMM trial.

The FDA granted accelerated approval to RP1 (vusolimogene oderparepvec; Tudriqev), an oncolytic virus therapy, in combination ...

Lifileucel was granted approval for the treatment of adults with unresectable or metastatic melanoma that has been previously treated with other therapies, marking the first approval of a ...

The FDA has granted accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for adults with ...

Beam Therapeutics has set its sights on an accelerated approval of its base editing therapy for the severe form of alpha-1 antitrypsin deficiency (AATD) following a positive Phase I/II trial readout.

ALK Tyrosine Kinase Inhibitors Induced Weight Gain: More Refined Definition of Weight Gain, Glucagon-Like Peptide-1 Agonist Treatment, and Therapeutic Drug Monitoring of ALK+ Non–Small Cell Lung ...

After several delays and a narrow advisory committee vote, Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy has finally won an accelerated approval. The FDA’s approval for Elevidys comes one ...