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RSS FeedPosted by Michael Wonder on 05 Feb 2021
FDA grants Actinogen rare paediatric disease designation in Fragile X syndrome
5 February 2021 - Actinogen is pleased to announce that the United States FDA has granted Actinogen’s drug Xanamem rare paediatric ...
Posted by Michael Wonder on 04 Feb 2021
Theratechnologies’ lead peptide drug conjugate TH1902 receives FDA fast track designation for the treatment of sortilin-expressing cancers
4 February 2021 - Theratechnologies is pleased to announce that the United States FDA has granted fast track designation to TH1902 ...
Posted by Michael Wonder on 03 Feb 2021
FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer
3 February 2021 - Today the FDA granted accelerated approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...
Posted by Michael Wonder on 03 Feb 2021
Asana BioSciences’ gusacitinib granted FDA fast track designation for moderate to severe chronic hand eczema
4 February 2021 - Asana BioSciences announced today that the U.S. FDA has granted fast track designation to Asana’s gusacitinib (ASN002), ...
Posted by Michael Wonder on 03 Feb 2021
BioCryst announces FDA approval of supplemental new drug application for Rapivab expanding patient population to include children six months and older
3 February 2021 - BioCryst Pharmaceuticals today announced that the U.S. FDA has approved a supplemental new drug application for ...
Posted by Michael Wonder on 03 Feb 2021
Durect Corporation announces U.S. FDA approval of Posimir for post-surgical pain reduction for up to 72 hours following arthroscopic subacromial decompression
2 February 2021 - POSIMIR is the only approved sustained release bupivacaine product indicated for up to 72 hours of post-surgical ...
Posted by Michael Wonder on 03 Feb 2021
Eagle Pharmaceuticals receives additional FDA questions regarding vasopressin; court date set for 7 July 2021 in vasopressin trial
2 February 2021 - Company expects it will have 180 days of exclusivity. ...
Posted by Michael Wonder on 03 Feb 2021
Geistlich Pharma granted FDA breakthrough device designation for Chondro-Gide articular cartilage cover
2 February 2021 - Geistlich Pharma announced that the Chondro-Gide articular cartilage cover has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 03 Feb 2021
Chinook receives rare paediatric disease designation from U.S. FDA for CHK-336 for treatment of primary hyperoxaluria
2 February 2021 - CHK-336 on track for Phase 1 clinical trial initiation in the second half of 2021. ...
Posted by Michael Wonder on 03 Feb 2021
Cerecor announces fast track designation for CERC-803 for the treatment of leukocyte adhesion deficiency type II
2 February 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-803 for the treatment ...
Posted by Michael Wonder on 02 Feb 2021
VBI Vaccines announces U.S. FDA acceptance of BLA filing for VBI’s 3 antigen prophylactic hepatitis B vaccine
2 February 2021 - FDA sets a target action date of 30 November 2021. ...
Posted by Michael Wonder on 02 Feb 2021
Mirum Pharmaceuticals announces completion of rolling NDA submission for maralixibat in Alagille syndrome
1 February 2021 - Maralixibat U.S. launch expected in second half of 2021, if approved. ...
Posted by Michael Wonder on 02 Feb 2021
Bristol Myers Squibb application for Zeposia (ozanimod) for the treatment of ulcerative colitis accepted for filing with priority review by U.S. FDA
1 February 2021 - U.S. Food and Drug Administration assigned an action date of 30 May 2021. ...
Posted by Michael Wonder on 01 Feb 2021
Vyne Therapeutics announces FDA approval of Amzeeq (minocycline) label ppdate
1 February 2021 - Vyne Therapeutics today announced approval by the U.S. FDA to include new information in the product ...
Posted by Michael Wonder on 01 Feb 2021
Adamas announces FDA approval for second indication for Gocovri as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing OFF episodes
1 February 2021 - Gocovri is now the first and only medication approved to treat OFF and dyskinesia motor complications. ...