US FDA grants Emergency Use Authorization to Novavax 2024 …
WEBSep 2, 2024 · Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced the Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for active immunization to ...
Astellas Pharma announces US FDA listing of DIGITIVA for the …
WEB16 hours ago · Tokyo. Friday, September 20, 2024, 11:00 Hrs [IST] Astellas Pharma Inc. announced that DIGITIVA, a non-invasive digital health solution for heart failure management, has been listed with the US Food and Drug Administration (FDA). DIGITIVA is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510 (k) premarket submission.
New Novartis data in relapsing MS reinforce benefits of Kesimpta …
WEB15 hours ago · Friday, September 20, 2024, 12:00 Hrs [IST] Novartis announced new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (=3 years) and treatment-naïve (RDTN) …
Roche announces phase III CENTERSTONE study of Xofluza …
WEB18 hours ago · Roche announced positive topline results of the phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with ...
SciSparc submits IND application to US FDA for phase IIb trial for ...
WEB9 hours ago · SciSparc submits IND application to US FDA for phase IIb trial for Tourette syndrome. Tel Aviv, Israel. Friday, September 20, 2024, 17:30 Hrs [IST] SciSparc Ltd., a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, has …
ME Therapeutics to begin testing of first mRNA formulations from ...
WEB13 hours ago · ME Therapeutics Holdings Inc, a pre-clinical stage biotechnology company working on novel cancer fighting drugs in the field of immuno-oncology, has announced the start of efficacy testing of the first two mRNA formulations from its strategic collaboration with NanoVation Therapeutics Inc. As ...
Daiichi Sankyo & AstraZeneca's Enhertu gets US FDA …
WEBAug 20, 2024 · Daiichi Sankyo & AstraZeneca's Enhertu gets US FDA breakthrough therapy designation for certain patients with HER2 low or HER2 ultralow metastatic breast cancer
Pfizer, BioNTech receive US FDA approval & authorization for …
WEBSaturday, August 24, 2024, 09:00 Hrs [IST] Pfizer Inc. and BioNTech SE announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (Covid-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 …
Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
WEBFriday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...
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