Jazz Pharmaceuticals plc announced that the FDA accepted for filing with Priority Review the company’s New Drug Application (NDA) seeking marketing approval for JZP 258, an investigational medicine… read more.
Takeda Pharmaceutical Company Limited announced that The Lancet published two papers related to Takeda’s dengue vaccine candidate (TAK 003), reporting on results from the 18-month analysis of the… read more.
Merck Inc., announced top-line efficacy results from two ongoing pivotal Phase III trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of gefapixant (MK 7264) , an investigational,… read more.
AveXis, a Novartis company, announced a one-time infusion of Zolgensma (onasemnogene abeparvovec-xioi) showed rapid, significant and clinically meaningful therapeutic benefit in patients with spinal muscular atrophy (SMA) across… read more.
Pfizer Inc announced that the FDA has approved its supplemental New Drug Application (sNDA) for Eucrisa (crisaborole) ointment, 2%, extending the lower age limit from 24 months down… read more.
The FDA has issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for… read more.
Oncology Venture has had a meeting with the FDA to discuss a potential path to approval for dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the… read more.
Regeneron Pharmaceuticals, Inc. and Sanofi announced they have started a clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection . Kevzara is a fully-human monoclonal… read more.
Cepheid announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative… read more.
Novo Nordisk announced that two clinical trials in the concizumab phase III programme (explorer7 and 8) and one clinical trial in the phase II programme (explorer5) have been… read more.
Aurinia Pharmaceuticals announced that the Company has initiated a Rolling Submission of its New Drug Application to the FDA for Luveniq (voclosporin), a next-generation calcineurin inhibitor for the… read more.
UCB, a global biopharmaceutical company, announced top-line results from ARISE (NCT03373383), the first of two adequate and well-controlled studies, investigating the efficacy and safety of padsevonil for the… read more.
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