The firm intends to launch the trial based on positive results from an open-label Phase I/IIa trial of sasineprocel, previously known as ANPD001.

The new Andelyn Foundation plans to financially support one patient- or family-founded rare disease charity every year.

The deal will give Novartis SNV4818, which is designed to more precisely target PIK3CA-mutated cancer cells and may avoid the toxicities seen with Piqray, the company hopes.

The companies have identified an initial set of genetic biomarkers to predict drug response and will validate the findings in ...

The firm is preparing to submit supplemental NDAs for Vyondys 53 and Amondys 45 with results from a failed confirmatory trial and real-world data.

The groups are calling for genotype-informed prevention and treatment strategies, APOE stratification in clinical trials, and related public policies.

After a meeting with the FDA, the company believes the agency is aligned with its development plan to start a Phase III registrational trial in CLDN 18.2-, PD-L1-positive tumors.

The government hopes to limit cases in which NICE determines a treatment isn't cost effective after the MHRA has deemed it ...

Last week, the company got the FDA's tentative approval for the radioligand therapy, but a judge may soon decide whether it's ...

The Shenzhen, China-based biotech plans to launch a Phase I trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026.

BobcatBio brought on the contract development and manufacturing organization to support manufacturing for ongoing Phase I studies in lymphoma and solid tumors.

Early clinical data indicates the treatment leads to dose-dependent increases in functional AAT protein, which is altered in the condition.