The firm said it will rely on academic partnerships and contract manufacturers to support its cell therapy clinical trials.
SciClone will develop and distribute Tasfygo in greater China but Eisai will retain worldwide rights outside the region.
Approval would expand the use of Enhertu to breast cancer patients with nearly undetectable HER2 levels in their tumors.
The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.
Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.
The committee supports approving the CFTR modulator for patients 2 years and older with at least one non-class I CFTR gene mutation.
Researchers warn NIH divestment from research could hinder progress at a pivotal moment for advances in precision cancer medicine.
In a recent trial, researchers found that Xpovio plus chemo had activity in NSCLC patients with KRAS mutations other than ...
The firm's biologics license application for TLX250-CDx was granted priority review and a decision is expected in August.
The platform will enable on-site molecular profiling of liquid biopsy samples for cancer patient monitoring and treatment response prediction.
Based on early Phase I/II data, investigators at Cincinnati Children's are enrolling more patients with a telomere biology ...