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
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
The medicine is now approved for eight indications across five different types of cancer in China.
The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours
The trial will be conducted across 10 sites in India
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
Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
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