October 2025 proved to be a significant month for the oncology landscape, marked by a wave of key regulatory decisions from ...
In October 2025, the U.S. Food and Drug Administration (FDA) granted approval to multiple new cancer therapies and supportive ...
Libtayo is approved for adjuvant treatment in high-risk CSCC patients post-surgery and radiation, showing significant disease-free survival benefits in the C-POST trial. The C-POST trial excluded ...
Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell therapy candidate for the treatment of cardiomyopathy associated with ...
Lifileucel shows a 25.6% objective response rate and 71.8% disease control rate in advanced nonsquamous NSCLC patients, ...
DUBLIN, Oct. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in ...
FDA approves cancer drug belantamab mafodotin-blmf for relapsed multiple myeloma in combination with bortezomib and dexamethasone.
"FDA halts uniQure’s plans for Huntington’s disease gene therapy" was originally created and published by Pharmaceutical ...
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug Administration (FDA) ...
Stem cell transplants that are a standard treatment for certain blood cancers are out of reach for many patients. The procedure requires cells from a matched donor, but a match isn’t always available.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® ...