Blog
RSS FeedPosted by Michael Wonder on 17 Dec 2020
Amgen submits sotorasib new drug application to U.S. FDA for advanced or metastatic non-small cell lung cancer with KRAS G12C mutation
16 December 2020 - FDA granted breakthrough therapy designation for Sotorasib. ...
Posted by Michael Wonder on 16 Dec 2020
FDA authorises marketing of new implant to repair a torn anterior cruciate ligament
16 December 2020 - Today, the U.S. FDA granted marketing authorisation—under the De Novo premarket review pathway—for an anterior cruciate ligament ...
Posted by Michael Wonder on 16 Dec 2020
Durect Corporation announces DUR-928 granted FDA fast track designation for treatment of alcoholic hepatitis
16 December 2020 - Durect Corporation today announced that the U.S. FDA has granted fast track designation to DUR-928 for ...
Posted by Michael Wonder on 16 Dec 2020
In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...
Posted by Michael Wonder on 16 Dec 2020
Gilead and Galapagos announce new commercialisation and development agreement for Jyseleca (filgotinib)
15 December 2020 - Gilead will not advance Jyseleca for the treatment of rheumatoid arthritis in the U.S. following FDA Type ...
Posted by Michael Wonder on 16 Dec 2020
Fortress Biotech announces breakthrough therapy designation for CUTX-101, copper histidinate, for the treatment of Menkes disease
15 December 2020 - Rolling submission of new drug application to the FDA for CUTX-101 on track to begin in the ...
Posted by Michael Wonder on 16 Dec 2020
Spark Biomedical receives FDA breakthrough device designation for infant transcutaneous auricular neurostimulation device, the Roo system
15 December 2020 - Breakthrough designation helps advance the therapy targeting a significant unmet need in the treatment of neonatal opioid ...
Posted by Michael Wonder on 16 Dec 2020
Exero Medical's smart sensor granted FDA breakthrough designation
15 December 2020 - Designation to expedite regulatory clearance process for Exero Medical's system, providing data on internal tissue healing in ...
Posted by Michael Wonder on 16 Dec 2020
US FDA approves world’s first rapid Covid test from Brisbane’s Ellume
16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...
Posted by Michael Wonder on 15 Dec 2020
FDA committee to meet again Thursday for Moderna's COVID-19 vaccine
14 December 2020 - A Food and Drug Administration advisory committee will meet for the second time in a week to ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 15 Dec 2020
FDA awards Genetesis breakthrough device designation for CardioFlux imaging technology
15 December 2020 - Genetesis announced today that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the U.S. ...
Posted by Michael Wonder on 15 Dec 2020
Almirall announces FDA approval of Klisyri (tirbanibulin), a new innovative topical treatment for actinic keratosis
15 December 2020 - In one of the largest Phase 3 clinical trial programs ever conducted for a topical actinic keratosis ...
Posted by Michael Wonder on 15 Dec 2020
FDA approves Genentech’s Ocrevus (ocrelizumab) shorter 2 hour infusion for relapsing and primary progressive multiple sclerosis
14 December 2020 - Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional ...