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ADMA Biologics Opens New Plasma Collection Facility
contractpharma
July 07, 2020
Aims to open 5 to 10 more collection centers by the end of 2022.
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FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional
fda
July 06, 2020
The U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body ...
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Oncternal gets FDA orphan drug designations for cirmtuzumab to treat MCL and CLL
pharmaceutical-business-review
July 06, 2020
Oncternal Therapeutics announced that the United States Food and Drug Administration (FDA) has granted the company orphan drug designations of cirmtuzumab for treatment of mantle cell lymphoma (MCL) and for treatment of chronic lymphocytic leukaemia ...
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US FDA approves GSK’s HIV drug for patients with limited options
expresspharma
July 06, 2020
The oral treatment from the company’s HIV unit, ViiV Healthcare, has been approved for adults whose HIV infection could not be successfully treated with other therapies due to resistance, intolerance or safety considerations.
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Indian pharma firms recall medications from US market
expresspharma
July 06, 2020
Lupin and Marksans Pharma recall diabetes drugs while Alembic and Aurbindo recall medicines that treat mental disorders.
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FDA approves ViiV's novel HIV treatment Rukobia
pharmatimes
July 03, 2020
The US Food and Drug Administration (FDA) has approved ViiV Healthcare's novel attachment inhibitor Rukobia (fostemsavir) expanding treatment options for HIV.
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FDA Approves Selinexor for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
americanpharmaceuticalreview
July 03, 2020
The Food and Drug Administration (FDA) granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) ...
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Reneo Receives FDA Orphan Drug Designation for Primary Mitochondrial Myopathies Treatment
americanpharmaceuticalreview
July 03, 2020
Reneo Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of primary mitochondrial myopathies ...
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Virality Diagnostics Antibody Test Wins FDA EUA
americanpharmaceuticalreview
July 03, 2020
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics, manufactured by Biohit (Hefei).
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FDA Approves Pembrolizumab for Cutaneous Squamous Cell Carcinoma
americanpharmaceuticalreview
July 03, 2020
The Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.