Drug Approval | September 12, 2021
US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours
Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020
Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care
Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months
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The company aims to continue its expansion via organic and inorganic routes to increase production capacity and product portfolio
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