Bristol-Myers Squibb Company and Acceleron Pharma Inc. announced that the New England Journal of Medicine (NEJM) has published results from BELIEVE, the pivotal Phase III study evaluating the… read more.
Merck KGaA announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tepmetko (tepotinib) for the treatment of patients with unresectable, advanced or recurrent non-small… read more.
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.
Novavax, Inc. announced positive top-line results of its pivotal Phase III clinical trial of NanoFlu , its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant,… read more.
OPKO Health reported interim results from an ongoing Phase IV clinical trial comparing Rayaldee with three common treatment regimens for secondary hyperparathyroidism (SHPT) in adult patients with stage… read more.
Eurobio Scientific announced CE mark approval for its EBX 041 SARS CoV2 proprietary test, developed specifically for the clinical diagnosis of COVID-19. The EBX 041 SARS CoV2 proprietary… 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.
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.
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.
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.
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