Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)
Unani Medicine facilities to be upgraded at Hyderabad, Chennai, Lucknow, Silchar and Bengaluru
First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India
Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
The one-year-long study was aimed to evaluate the efficacy of LDH's digital therapeutics platform
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