Phase III
Weeks after the FDA rejected Veru’s Emergency Use Authorization bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.
Acadia Pharmaceuticals announced the approval of Daybue (trofinetide) as the first and only drug to treat Rett Syndrome, a rare, neurodegenerative disorder affecting primarily girls.
AstraZeneca reported positive data from both the Phase III ADAURA trial studying Tagrisso (osimertinib) and the Phase III AEGEAN studying Imfinzi (durvalumab) in NSCLC patients.
Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease.
An independent panel of advisers voted to approve Genentech’s Polivy after internal FDA staff raised concerns regarding the efficacy and risk-benefit profile as a first-line treatment for large B-cell lymphoma.
With the results from the CLEAR outcomes study, Esperion is poised for a major inflection in sales and is targeting blockbuster status, said CEO Sheldon Koenig on an investor call Monday.
Incyte Corporation’s Phase III LIMBER-304 clinical trial has come to an end following a third-party investigation that forecasted poor results.
Phase III data showed the combination of Roche’s Tecentriq and Exelixis’ Cabometyx fell short of its primary endpoint in renal cell carcinoma.
Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
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