The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The approval is supported by data from three pivotal clinical trials
This agreement will enhance Lupin’s gastroenterology portfolio and expand its presence in emerging markets
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy
Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days
Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population
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