GlaxoSmithKline's Augmentin ES-600 labeling for otitis media sets a limit on the S. pneumoniae penicillin-resistant strains the antibiotic is expected to effectively treat.
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US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.
The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.
