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RSS FeedPosted by Michael Wonder on 30 Jul 2020
Merck announces two US regulatory milestones for Keytruda (pembrolizumab) in triple-negative breast cancer
30 July 2020 - FDA grants priority review to supplemental biologics license application for Keytruda plus chemotherapy for the treatment of ...
Posted by Michael Wonder on 28 Jul 2020
HemoShear Therapeutics receives FDA fast track and rare paediatric disease designations for HST5040 to treat methylmalonic acidaemia and propionic acidaemia
28 July 2020 - HemoShear Therapeutics has received fast track and rare paediatric disease designations from the U.S. FDA for ...
Posted by Michael Wonder on 28 Jul 2020
Momenta Pharmaceuticals announces FDA rare paediatric disease designation for nipocalimab in HDFN
28 July 2020 - Momenta Pharmaceuticals today announced that its novel drug candidate, nipocalimab, has received rare paediatric disease designation ...
Posted by Michael Wonder on 28 Jul 2020
Lumos Pharma announces sale of priority review voucher
27 July 2020 - ) -- Lumos Pharma today announced that it has entered into a definitive agreement to sell ...
Posted by Michael Wonder on 16 Jul 2020
FDA grants priority review to Merck’s new drug application for vericiguat
16 July 2020 - Application based on first contemporary outcomes study focused exclusively on chronic heart failure patient population following a ...
Posted by Michael Wonder on 16 Jul 2020
Knopp Biosciences receives rare paediatric disease designation for Kv7 activator KB-3061 for treatment of KCNQ2 epileptic encephalopathy
15 July 2020 - Knopp Biosciences announced today that it has received rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 09 Jul 2020
Brilinta granted FDA priority review for the reduction of subsequent stroke in patients who had an acute ischaemic stroke or transient ischaemic attack
9 July 2020 - Brilinta in combination with aspirin could be the first FDA approved dual anti-platelet therapy to reduce the ...
Posted by Michael Wonder on 07 Jul 2020
Senhwa Biosciences's silmitasertib receives rare paediatric disease designation from U.S. FDA for treatment of recurrent sonic hedgehog medulloblastoma
7 July 2020 - Senhwa Biosciences today announced that the U.S. FDA granted rare paediatric disease designation for its drug silmitasertib, ...
Posted by Michael Wonder on 02 Jul 2020
Rhythm Pharmaceuticals receives rare paediatric disease designation from U.S. FDA for setmelanotide for treatment of POMC and LEPR deficiency obesities
1 July 2020 - Rhythm Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designations for setmelanotide, an ...
Posted by Michael Wonder on 23 Jun 2020
Myovant Sciences announces priority review and FDA acceptance of new drug application for once daily, oral relugolix for advanced prostate cancer
22 June 2020 - Priority review status expected to accelerate review, with a target FDA action date of 20 December ...
Posted 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 ...