Drug Approval | October 16, 2024
Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)
Survodutide has potential to become best-in-class treatment for metabolic dysfunction-associated steatohepatitis
Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America
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
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