Summary : With the FDA’s emergency use authorization today of AstraZeneca’s long-acting antibody cocktail, the roughly 2% of U.S. residents who are…
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FDA
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AgrochemicalsNuvation Bio
Nuvation Bio Announces FDA Clearance to begin Clinical Trail of NUV-422 for Breast Cancer Treatment.
by adminby adminSummary – U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422. It is a…
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Synopsis: The FDA’s authorization expands the drug’s use to fight Covid-19 to people under the age of 12 The therapy, Bamlanivimab plus…
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Synopsis- Otezla trumped placebo in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis, top-line results from Amgen’s…
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Agrochemicals
Therapixel receives FDA 510(k) Clearance for use of its AI-based Breast Cancer Screening Software MammoScreen on Digital Breast Tomosynthesis
by adminby adminSYNOPSIS: New 510(k) clearance expands the use of MammoScreen from 2D to 3D mammography, opening up the entire breast cancer screening market.…
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RegulatoryU.S FDA
On Target Laboratories has received FDA Approval for the Injectable CYTALUXTM (Pafolacianine) for the Detection of Ovarian Cancer during Surgery.
by adminby adminThe FDA has approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions, according to…
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Agrochemicals
The USFDA Grants Orphan Drug Designation to CT120 a Novel CAR T-Cell Therapy of IASO Biotherapeutics for Acute Lymphoblastic Leukemia
by adminby adminKEYPOINTS: The FDA has granted orphan drug designation (ODD) to CT120 for the treatment of acute lymphoblastic leukemia, a novel chimeric antigen…
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Agrochemicals
US FDA Grants Orphan Drug Designation to Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy, GC012F to Treat Multiple Myeloma.
by adminby adminSynopsis: The FDA granted orphan drug designation to GC012F, a novel chimeric antigen receptor T-cell therapy for the treatment of relapsed or…
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Agrochemicals
FDA Grants AppliedVR Approval for First Virtual Reality Therapeutic to Treat Chronic Low Back Pain.
by adminby adminSUMMARY: The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive…
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Ropeginterferon
FDA Approves Ropeginterferon Alfa-2b-njft (Besremi) Treatment for Rare Blood Disease Polycythemia Vera (PV).
by adminby adminSUMMARY: PharmaEssentia Corporation a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in…