Phase III
The investigational oral drug for vasomotor symptoms in menopause women couldn’t meet the pre-defined efficacy. Here’s how it performed during the clinical stages.
Incyte Corporation reported that the FDA has pushed back the review of the company’s supplemental New Drug Application (sNDA) for Opzelura (ruxolitinib cream) for vitiligo.
In the latest results shared by the company, treatment with nusinersen for a median of 4.9 years helped participants maintain and make progressive gains in motor function.
The U.S. FDA has approved Lynparza for the adjuvant treatment of patients diagnosed with germline BRCA-mutated HER2-negative high-risk early breast cancer.
Novartis released new data Monday from its Phase III SPR1NT trial that reinforces the benefits of Zolgensma.
This week is starting off strong with some positive clinical news from Ascendis Pharma, Can-Fite and BridgeBio.
AstraZeneca’s Fasenra hit a roadblock after the FDA issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
Bristol Myers Squibb and Nektar Therapeutics said their joint Phase III PIVOT IO-001 study did not meet two endpoints: progression-free survival and objective response rate.
The FDA has a full PDUFA calendar for the second half of March for New Drug Applications and Biologics License Applications. Here’s a look.
Across a range of indications, COVID-19-related and non-COVID-19-related, there was plenty of clinical trial news last week.
PRESS RELEASES