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RSS FeedPosted by Michael Wonder on 16 Feb 2022
3D printing medical devices: stakeholders weigh in on FDA’s discussion paper
15 February 2022 - The US FDA has started thinking about how 3D printing of medical devices at the point ...
Posted by Michael Wonder on 16 Feb 2022
U.S. FDA accepts Mirati Therapeutics' new drug application for adagrasib as treatment of previously treated KRAS G12C mutated non-small cell lung cancer
15 February 2022 - Mirati Therapeutics today announced that the U.S. FDA accepted the new drug application for adagrasib for ...
Posted by Michael Wonder on 16 Feb 2022
Foundation Medicine’s ctDNA monitoring assay, FoundationOne Tracker, granted breakthrough device designation by U.S. Food and Drug Administration
15 February 2022 - Foundation Medicine today announced that the U.S. FDA has granted a breakthrough device designation for its circulating ...
Posted by Michael Wonder on 16 Feb 2022
Pfizer and OPKO’s once weekly Ngenla (somatrogon) injection receives marketing authorisation in European Union for treatment of paediatric growth hormone deficiency
15 February 2022 - Pfizer and OPKO Health announced today that the European Commission has granted marketing authorisation for the next ...
Posted by Michael Wonder on 16 Feb 2022
Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus
16 February 2022 - Saphnelo is a first in class type I interferon receptor antibody and the only new medicine ...
Posted by Michael Wonder on 16 Feb 2022
European Medicines Agency approves Pfizer’s 20 valent pneumococcal conjugate vaccine against invasive pneumococcal disease and pneumonia in adults
15 February 2022 - Apexxnar [pneumococcal polysaccharide conjugate vaccine (20 valent, adsorbed)] is the first pneumococcal conjugate vaccine to help protect ...
Posted by Michael Wonder on 16 Feb 2022
Cardiosense receives FDA breakthrough device designation for algorithm to identify patients at risk of decompensated heart failure
15 February 2022 - Cardiosense announced today that the U.S. FDA has granted the company breakthrough device status for its ...
Posted by Michael Wonder on 16 Feb 2022
Rapid Medical receives FDA breakthrough device designation for vasospasm treatment
15 February 2022 - Comaneci temporarily expands blood vessels, recognised as novel device for life-threatening disease. ...
Posted by Michael Wonder on 16 Feb 2022
GE Healthcare's stress agent Rapiscan approved for use in stress cardiac magnetic resonance imaging
14 February 2022 - Already used in single photon emission computed tomography (SPECT) myocardial perfusion imaging for adult patients, Rapiscan is ...
Posted by Michael Wonder on 15 Feb 2022
Theradaptive wins additional FDA breakthrough designation for spinal fusion
15 February 2022 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation for its OsteoAdapt SP Spinal ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 15 Feb 2022
Human medicines: highlights of 2021
15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...
Posted by Michael Wonder on 15 Feb 2022
Biogen Alzheimer drug row augers flux in fast FDA approvals
14 February 2022 - Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation ...
Posted by Michael Wonder on 15 Feb 2022
Senate confirms Califf as FDA chief in tight vote
15 February 2022 - The narrow 50-46 decision underscored the divisions on both sides of the aisle over agency policies on ...
Posted by Michael Wonder on 15 Feb 2022
With no votes to spare, Senate advances Califf’s FDA nomination toward final vote
14 February 2022 - In a dramatically close procedural vote Monday night, the Senate voted 49-45 to advance Robert Califf’s ...