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 drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours
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
The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers
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