XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
The companies plan to start a pivotal Phase 3 trial in the coming months
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
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
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.
The plan is to advance innovative therapies to drug-resistant cancers
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