In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval. FDA announced a draft guidance on Dec. 5, 2024 that explains the procedures and criteria ...

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...

Revuforj, a menin inhibitor, is approved for relapsed/refractory NPM1-mutant AML, offering new hope for patients with limited treatment options. Blenrep combined with Velcade and dexamethasone ...

There’s been a lot of talk about speeding up drug approval at FDA. So just how fast can approval be? Leela Barham takes a look at the speed of approval for each of FDA's expedited development and ...

From a global regulatory perspective, Cytokinetics is expanding its footprint rapidly. The drug received approval in China on ...

A new FDA approval for a first-in-class drug has vaulted Otsuka into immunoglobulin A nephropathy (IgAN), an increasingly competitive kidney disease field targeted by multiple biopharma companies. The ...

Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...

ImmunoGen, Inc. has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. This first FDA antibody-drug conjugate ...

The Food and Drug Administration on Tuesday quietly approved a generic form of mifepristone, one of the two medications used in most U.S. abortions. That makes the drug, from the company Evita ...

Artificial intelligence (AI) is transforming the pharmaceutical industry, revolutionising drug discovery and approval processes, and reshaping how researchers identify potential drug candidates, ...

Before a drug can reach a patient, it must go through rigorous testing to determine whether it is safe, effective at treating the condition it was developed for, and to ascertain the correct dosage ...