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KalVista Pharmaceuticals Announces UK MHRA Approval of EKTERLY® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema

EKTERLY to be added to the Orphan Register and awarded 10 years of market exclusivity The MHRA’s marketing authorization for EKTERLY is based on results from the phase 3 KONFIDENT clinical trial, ...
Targeted Oncology

FDA Grants Orphan Drug Designation to Irinotecan Delivery Implant for High-Grade Glioma

The FDA has granted orphan drug designation (ODD) to a locally delivered formulation of irinotecan (ChemoSeed) for the ...
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United Kingdom’s MHRA Approves YORVIPATH® (palopegteriparatide) in Great Britain for the Treatment of Adults with Chronic Hypoparathyroidism

COPENHAGEN, Denmark, April 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (ASND) today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted ...
KTLA

AAVantgarde Announces FDA Orphan Drug Designation and UK CTA approval for AAVB-039 for the Treatment of Stargardt Disease

AAVB-039 addresses the root cause of the disease, benefitting patients with any ABCA4 mutation AAVB-039 is currently being assessed in the CELESTE interventional clinical trial and we continue ...