FDA lifts hold on Rocket Pharma's gene therapy trial
Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort
Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
Xtandi is approved in over 80 countries, including the U.S., EU, and Japan
Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment
CSIR-IGIB advances indigenous CRISPR Trials on sickle cell anaemia, anti-microbial resistance, liver fibrosis and rare disorders
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
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