Cantex Pharmaceuticals, a Florida-based biotech company, has secured the fast track designation for its acute myeloid leukemia drug CX-01 from the US Food and Drug Administration (FDA). The FDA fast track designation for CX-01 is for the treatment of patients, aged over 60, who are being subjected to induction therapy for newly diagnosed acute myeloid […]
Continue reading …Ortho Dermatologics bags FDA approval for Altreno lotion for acne treatment
August 25, 2018 No Comment
Altreno FDA approval : Ortho Dermatologics, a division of Bausch Health Companies, has bagged approval from the US Food and Drug Administration (FDA) for Altreno lotion (tretinoin 0.05%) for the topical treatment of acne vulgaris in patients aged 9 years and older. According to Bausch Health Companies, Altreno is the first formulation of tretinoin in […]
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Oxervate FDA approval : Italian pharma company Dompé farmaceutici has bagged an approval for Oxervate (cenegermin) eye drops from the US Food and Drug Administration (FDA) for the treatment of a rare eye disease called neurotrophic keratitis. Oxervate is now the first US FDA approved drug for neurotrophic keratitis treatment. A degenerative disease, neurotrophic keratitis […]
Continue reading …Aravive Biologics ovarian cancer drug AVB-S6-500 gets FDA fast track designation
August 20, 2018 No Comment
Aravive Biologics has secured fast track designation from the US Food and Drug Administration (FDA) for its ovarian cancer drug AVB-S6-500 for the treatment of platinum-resistant recurrent ovarian cancer. A high-affinity, soluble Fc-fusion protein, AVB-S6-500 has been designed to prevent the activation of the GAS6-AXL signaling pathway. The drug functions by intercepting the binding of […]
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CEQUA FDA approval : Sun Pharmaceutical Industries has secured approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the US Food and Drug Administration (FDA) to increase tear production in patients having keratoconjunctivitis sicca (dry eye). According to Sun Pharma, CEQUA is a calcineurin inhibitor immunosuppressant which offers the highest FDA-approved concentration of cyclosporine A (CsA). […]
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The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) by Regeneron Pharmaceuticals for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). Regeneron Pharmaceuticals said that the sBLA is supported by second-year data recorded from the phase 3 VIEW 1 and 2 trials in which patients […]
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Lenvima FDA appoval : Eisai and Merck announced that the US Food and Drug Administration (FDA) has approved their kinase inhibitor Lenvima (lenvatinib) capsules for first-line treatment of hepatocellular carcinoma (HCC), a common type of primary liver cancer adults. Lenvima FDA approval, which is for HCC that is unresectable, was driven by results of the […]
Continue reading …Array BioPharma Braftovi triple combo for metastatic colorectal cancer secures FDA breakthrough therapy designation
August 8, 2018 No Comment
Array BioPharma secured breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI), in combination with binimetinib (MEKTOVI) and cetuximab for the treatment of patients with a specific form of metastatic colorectal cancer (mCRC). The breakthrough therapy designation is for metastatic colorectal cancer patients who are positive to BRAFV600E mutation as […]
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Spanish pharma company PharmaMar’s lurbinectedin has secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer. Lurbinectedin has been designed to inhibit the RNA polymerase II enzyme which is important for the transcription process that is over-activated in tumors with transcription addiction, according to PharmaMar. […]
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Tibsovo (ivosidenib) developed by Agios Pharmaceuticals has been approved by the US Food and Drug Administration (FDA) for acute myeloid leukemia treatment in patients with a specific genetic mutation and whose condition relapsed or is refractory. The Agios AML drug has been indicated to be used with an FDA-approved companion diagnostic that will detect specific […]
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- Abu Dhabi’s ADIA to invest $752m in Reliance’s Jio Platforms
- Orbital Science wins NASA Gateway contract to enable human habitation
