Phase III
Milestone Pharmaceuticals reported highly positive data from its Phase III RAPID trial of etripamil in paroxysmal supraventricular tachycardia (PSVT) patients.
Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD).
The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..
Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.
Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.
Novartis’ gene therapy Zolgensma is again under a cloud of doubt after Nature Biotechnology retracted its 2010 article noting “issues” regarding data cited in a key figure in the report.
Albireo Pharma reported dazzling Phase III ASSERT data of Bylvay for Alagille syndrome (ALGS). The company is headed to U.S. and European regulators with expectations of regulatory filings in Q1 of 2023.
Data from an ongoing Phase III trial showed Sanofi/Regeneron’s Dupixent can induce histological disease remission in young EoE patients aged 1–11.
SIFI, BeiGene and Novo Holdings shared promising updates on their proposed treatments for acanthamoeba keratitis, relapsed or refractory CCL and myasthenia gravis.
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