Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2022
U.S. Food and Drug Administration approves first LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab-rmbw), as treatment for patients with unresectable or metastatic melanoma
18 March 2022 - Opdualag is a first in class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and ...
Posted by Michael Wonder on 18 Mar 2022
Moderna submits amendment to the emergency use authorisation for an additional booster dose of its COVID-19 vaccine in the U.S.
17 March 2022 - Moderna today announced that it has submitted a request to the U.S. FDA for an amendment ...
Posted by Michael Wonder on 18 Mar 2022
Marinus Pharmaceuticals announces FDA approval of Ztalmy (ganaxolone) for CDKL5 deficiency disorder
18 March 2022 - Rare paediatric disease priority review voucher awarded to Marinus Pharmaceuticals by the FDA. ...
Posted by Michael Wonder on 17 Mar 2022
Panel scrutinises quick FDA drug approvals
17 March 2022 - A House committee will spotlight an FDA process that’s been criticised as putting some of the ...
Posted by Michael Wonder on 17 Mar 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions or exon 21 substitutions in non-small cell lung cancer
17 March 2022 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved ...
Posted by Michael Wonder on 17 Mar 2022
Aquestive Therapeutics receives FDA fast track designation for AQST-109 for emergency treatment of allergic reactions including anaphylaxis
17 March 2022 - Aquestive Therapeutics today announced that the U.S. FDA has granted fast track designation to AQST-109, the first ...
Posted by Michael Wonder on 16 Mar 2022
Rinvoq (upadacitinib) receives FDA approval for the treatment of adults with moderately to severely active ulcerative colitis
16 March 2022 - In clinical trials, Rinvoq (upadacitinib) achieved the primary endpoints of clinical remission (per modified Mayo Score) at ...
Posted by Michael Wonder on 16 Mar 2022
Consequences of lack of funding for efforts to combat COVID-19 if Congress does not act
15 March 2022 - The U.S. has made tremendous progress in our fight against COVID-19. ...
Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 16 Mar 2022
Pfizer and BioNTech submit for U.S. emergency use authorisation of an additional booster dose of their COVID-19 vaccine for older adults
15 March 2022 - Submission based on real-world safety and efficacy data from Israel. ...
Posted by Michael Wonder on 15 Mar 2022
FDA approves first generic of Symbicort to treat asthma and COPD
15 March 2022 - Agency supports development of complex generic drug-device combination product to improve competition and access to more affordable ...
Posted by Michael Wonder on 15 Mar 2022
Myrtelle receives FDA fast track, rare paediatric disease, and orphan drug designations for its proprietary gene therapy for the treatment of Canavan disease
15 March 2022 - Myrtelle today announced that the U.S. FDA has granted fast track, rare paediatric disease and orphan ...
Posted by Michael Wonder on 15 Mar 2022
Collider bias
14 March 2022 - Bias is a systematic, non-random error in the estimation of a treatment effect or the effect of ...
Posted by Michael Wonder on 14 Mar 2022
Incyte announces U.S. FDA has extended the supplemental new drug application review period for ruxolitinib cream (Opzelura) for the treatment of vitiligo
14 March 2022 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...
Posted by Michael Wonder on 14 Mar 2022
Corium receives FDA approval of Adlarity (donepezil transdermal system) for treatment of patients with Alzheimer's disease
14 March 2022 - First and only once weekly patch for convenient, well-tolerated delivery of most used drug for treatment of ...