Accelerated Approval Program News Today

Kintara Therapeutics and TuHURA Biosciences Enter into Definitive Merger ...

LLY earnings call for the period ending December 31, 2023.

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial ELREXFIO is an off-the-shelf ,...

08.12.2023 - Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO (elranatamab). ELREFXIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory ...

The Center for Medicare and Medicaid Innovation (CMMI) has provided new updates on CMS’ planned initiatives to address prescription drug costs in a blog post from Director Liz Fowler....

The FDA’s accelerated-approval process was designed to help people access life-saving drugs. But gaps in communication could mean that people are undergoing treatments known to be ineffective. The FDA’s accelerated-approval process was designed to help people access life-saving drugs. But gaps in communication could mean that people are undergoing treatments known to be ineffective.

/PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary,...

The U.S. Food and Drug Administration (FDA) has approved a drug for treating patients with a rare form of a neurological disease called amyotrophic lateral sclerosis (ALS).

Blood-based measurement of neurofilament light chain provides compelling evidence to support an accelerated drug approval by the FDA. The decision has positive implications for NfL blood testing as... | June 18, 2023

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