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RSS FeedPosted by Michael Wonder on 20 Jun 2020
Plakous Therapeutics receives rare paediatric disease and orphan drug designations for Protego-PDTM for the prevention of necrotising enterocolitis
18 June 2020 - Plakous Therapeutics has been granted orphan drug and rare paediatric disease designations for its human placental extract, ...
Posted by Michael Wonder on 20 Jun 2020
Ovid Therapeutics receives FDA rare paediatric disease designation for OV101 for the treatment of Angelman syndrome
19 June 2020 - Ovid Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease ...
Posted by Michael Wonder on 11 Jun 2020
Rezolute receives rare paediatric disease designation for RZ358, Phase 2b candidate for the treatment of congenital hyperinsulinism, enabling eligibility for priority review voucher
10 June 2020 - Rezolute today announced that the company has received rare paediatric disease designation from the FDA for ...
Posted by Michael Wonder on 10 Jun 2020
F2G’s olorofim receives both FDA orphan drug designation for Coccidioidomycosis (Valley fever) and FDA QIDP designation for multiple fungal infections
10 June 2020 - Olorofim is currently in Phase 2b development for the treatment of life-threatening fungal infections. ...
Posted by Michael Wonder on 03 Jun 2020
Clarity Pharmaceuticals announces that the US FDA grants rare paediatric disease designation to Copper Cu 67 sartate for the treatment of neuroblastoma
3 June 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 02 Jun 2020
Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review
2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...
Posted by Michael Wonder on 27 May 2020
FDA grants priority review of Nucala for patients with hypereosinophilic syndrome
27 May 2020 - An approval would give Nucala a third indication in an eosinophil driven disease. ...
Posted by Michael Wonder on 22 May 2020
Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis
21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...
Posted by Michael Wonder on 19 May 2020
Eiger BioPharmaceuticals announces FDA acceptance of NDA for filing with priority review of Zokinvy (lonafarnib) for treatment of progeria and progeroid laminopathies
19 May 2020 - Eiger BioPharmaceuticals today announced that the U.S. FDA accepted the new drug application for accelerated review of ...
Posted by Michael Wonder on 18 May 2020
Seelos Therapeutics receives rare paediatric disease designation for SLS-005 (trehalose) in Sanfilippo syndrome
15 May 2020 - Seelos Therapeutics today announced it has been granted rare paediatric disease designation for SLS-005 in Sanfilippo ...
Posted by Michael Wonder on 14 May 2020
FDA grants priority review of sutimlimab, potential first approved treatment of haemolysis in adult patients with cold agglutinin disease
14 May 2020 - Sutimlimab targets C1-activated haemolysis in cold agglutinin disease. ...
Posted by Michael Wonder on 11 May 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies
11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...
Posted by Michael Wonder on 07 May 2020
FDA grants paediatric disease designation for Mateon's CA4P
5 May 2020 - Treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect paediatric patients. ...
Posted by Michael Wonder on 06 May 2020
Immunicum receives regenerative medicine advanced therapy designation from FDA for ilixadencel in kidney cancer
6 May 2020 - Immunicum announced today that it has received regenerative medicine advanced therapy designation from the U.S. FDA for ...
Posted by Michael Wonder on 06 May 2020
Antabio receives FDA qualified infectious disease product designation for MEM-ANT3310, a novel broad-spectrum combination therapy targeting WHO’s priority pathogens
6 May 2020 - QIDP is granted to Antabio’s MEM-ANT3310 for major hospital indications including nosocomial pneumonia. ...