Phase III
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
Ravi B. Parikh discussed how new FDA guidance on accelerated approval for cancer drugs will affect the space.
GSK will help commercialize Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).
The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
Intra-Cellular Therapies’ Caplyta met its primary endpoint in the Phase III Study 403 trial, easing the burden of depressive episodes in patients with major depressive disorder or bipolar depression.
Monopar Therapeutics is dropping its lead candidate, Validive, after it failed to meet efficacy markers in Phase IIb/III trials for severe oral mucositis.
Merck’s Keytruda appeared to outperform GSK’s Jemperli in a key endometrial cancer patient subgroup, based on late-stage data revealed Monday during the Society of Gynecologic Oncology 2023 Annual Meeting.
Despite a tough financing market, ArriVent Biopharma closed a $155 million Series B to fund a pivotal Phase III trial of its non-small cell lung cancer asset.
Topline data from the Phase III NATALEE study showed Novartis’ Kisqali met its primary endpoint, reducing the risk of recurrence in early breast cancer.
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