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Catalyst Receives Fast Track Designation for Hemophilia Episodic Bleeding Treatment
americanpharmaceuticalreview
December 03, 2020
Catalyst Biosciences announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Marzeptacog alfa (activated) – or MarzAA, the Company’s subcutaneously (SQ) administered next-generation engineered coagulation ...
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FDA Lifts Hold on Multiple Myeloma Study
americanpharmaceuticalreview
December 03, 2020
Cellectis announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM).
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Genentech gets US FDA nod for Gavreto to treat RET-mutant, RET fusion-positive thyroid cancers
expresspharma
December 03, 2020
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.
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Rhizen Pharma gets USFDA approval for Phase I trials of COVID-19 drug
expresspharma
December 03, 2020
The initial study would evaluate single ascending doses of the RP7214 in healthy volunteers and that dosing is expected to commence in early December.
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Alembic Pharma gets final nod form US FDA for Metolazone Tablets
expresspharma
December 03, 2020
Metolazone Tablets are indicated for the treatment of salt and water retention and hypertension.
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FDA grants COVID-19 treatment Fast Track designation
europeanpharmaceuticalreview
December 02, 2020
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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Glenmark gets tentative approval from US FDA for Axitinib Tablets, 1 mg and 5 mg
expresspharma
December 02, 2020
Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (US FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta Tablets, 1 mg and 5 mg, of PF Prism C.V.
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Lupin gets US FDA approval for Penicillamine Tablets
expresspharma
December 02, 2020
They are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis.
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Rigel Finalizes Study Design of Fostamatinib Trial for Warm Autoimmune Hemolytic Anemia
americanpharmaceuticalreview
December 01, 2020
Rigel Pharmaceuticals has reached agreement with the U.S. Food and Drug Administration (FDA) on the final design of its FORWARD study, a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic ...
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Moderna announces vaccine efficacy of 94.1 per cent, to file for EUA with US FDA
expresspharma
December 01, 2020
Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe.