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RSS FeedPosted by Michael Wonder on 06 Feb 2021
FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma
5 February 2021 - Today, the Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase ...
Posted 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
EMA reviewing data on monoclonal antibody use for COVID-19
4 February 2021 - EMA’s CHMP is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and ...
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 04 Feb 2021
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
4 February 2021 - EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines ...
Posted by Michael Wonder on 04 Feb 2021
Repurposing of prescription medicines
4 February 2021 - The Therapeutic Goods Administration is conducting a public consultation that seeks to understand potential obstacles and ...
Posted by Michael Wonder on 04 Feb 2021
Aruvant announces the EMA granted PRIME designation to ARU-1801 for the treatment of sickle cell disease
3 February 2021 - Aruvant Sciences today announced that the EMA granted PRIME designation to ARU-1801, a one-time investigational gene therapy ...
Posted by Michael Wonder on 04 Feb 2021
Swiss medical regulator rejects Oxford/AstraZeneca COVID-19 vaccine
3 February 2021 - Switzerland’s medical regulator has said it cannot authorise use of the Oxford/AstraZeneca Covid-19 vaccine based on ...
Posted by Michael Wonder on 04 Feb 2021
EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
3 February 2021 - EMA’s CHMP has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax. ...
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
New toolbox available for EMA's PRIME designees
2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...