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RSS FeedPosted by Michael Wonder on 07 Aug 2020
FDA accepts Biogen's aducanumab biologics license application for Alzheimer's disease with priority review
7 August 2020 - If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease. ...
Posted by Michael Wonder on 07 Aug 2020
US FDA grants rare paediatric disease designation to paxalisib for DIPG
7 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has awarded rare paediatric disease designation ...
Posted by Michael Wonder on 05 Aug 2020
Cerecor receives rare paediatric disease designation for CERC-006 in lymphatic malformations
4 August 2020 - Cerecor today announced that the U.S. FDA granted rare paediatric disease designation to CERC-006, a dual inhibitor ...
Posted by Michael Wonder on 03 Aug 2020
Sonoran Biosciences announces qualified infectious disease product designation granted by FDA for SBG003 for surgical site infections in abdominal surgery
3 August 2020 - QIDP designation allows for FDA priority review, fast-track designation and an additional five years of market exclusivity ...
Posted by Michael Wonder on 30 Jul 2020
Marinus Pharmaceuticals receives rare paediatric disease designation from FDA for ganaxolone for the treatment of CDKL5 deficiency disorder
30 July 2020 - Marinus Pharmaceuticals announced today that the U.S. FDA has granted rare paediatric disease designation for the ...
Posted 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 ...