Shilpa Medicare aims for US approval of chemo nausea drug
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
NTX-253 is a potent, selective, orally available positive allosteric modulator (PAM) of the muscarinic M4 receptor
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
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
Under the agreement, Insilico could receive up to $32 million in upfront and near-term R&D payments
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The approval is supported by data from three pivotal clinical trials
Elanco expects Befrena to launch in the US in the first half of 2026
The company announced that it has been granted patent covering “Substituted Ethylamine Fused Heterocyclic Mescaline Derivatives.”
The funding will accelerate Sinopia’s data-driven drug discovery efforts
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