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RSS FeedPosted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
Posted by Michael Wonder on 23 Sep 2021
FDA authorises booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations
22 September 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine to allow ...
Posted by Michael Wonder on 22 Sep 2021
FDA approves ruxolitinib for chronic graft-versus-host disease
22 September 2021 - Today the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte) for chronic graft-versus-host disease after failure ...
Posted by Michael Wonder on 21 Sep 2021
bluebird bio submits biologics license application to FDA for betibeglogene autotemcel (beti-cel) gene therapy for patients with β-thalassaemia who require regular red blood cell transfusions
21 September 2021 - Biologics license application submission based on data from Phase 1/2 and Phase 3 Northstar studies, which ...
Posted by Michael Wonder on 21 Sep 2021
Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis
21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to ...
Posted by Michael Wonder on 21 Sep 2021
Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis
21 September 2021 - Opzelura is the first and only topical Janus kinase inhibitor approved in the United States. ...
Posted by Michael Wonder on 21 Sep 2021
U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)
21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...
Posted by Michael Wonder on 21 Sep 2021
FDA authorises software that can help identify prostate cancer
21 September 2021 - Today, the U.S. FDA authorised marketing of software to assist medical professionals who examine body tissues (pathologists) ...
Posted by Michael Wonder on 21 Sep 2021
FDA approves Lexette for adolescent plaque psoriasis
21 September 2021 - Mayne Pharma is pleased to announce that the U.S. FDA has approved Lexette (halobetasol propionate) foam, ...
Posted by Michael Wonder on 21 Sep 2021
Rhythm Pharmaceuticals completes submission of supplemental new drug application to U.S. Food and Drug Administration for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in Bardet-Biedl and Alström syndromes
20 September 2021 - Rhythm Pharmaceuticals today announced that it has completed its supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 20 Sep 2021
Abbott receives FDA approval for minimally invasive Portico with Flexnav TAVR system to treat patients with aortic valve disease
20 September 2021 - Transcatheter aortic valve replacement procedure treats people with symptomatic, severe aortic stenosis who are at high or ...
Posted by Michael Wonder on 20 Sep 2021
Seagen and Genmab announce FDA accelerated approval for Tivdak (tisotumab vedotin-tftv) in previously treated recurrent or metastatic cervical cancer
20 September 2021 - Seagen and Genmab today announced that the U.S. FDA has granted accelerated approval to Tivdak (tisotumab ...
Posted by Michael Wonder on 20 Sep 2021
Alvotech provides update on FDA action regarding AVT02, proposed high concentration biosimilar to Humira (adalimumab)
20 September 2021 - Alvotech today announced that the FDA is deferring action on the application for AVT02, the company’s proposed ...
Posted by Michael Wonder on 20 Sep 2021
Verrica Pharmaceuticals receives complete response letter from the FDA identifying deficiencies at a facility of a contract manufacturer for its new drug application for VP-102 for the treatment of molluscum contagiosum
20 September 2021 - No specific deficiencies related to the manufacturing of VP-102 identified by FDA in its general inspection of ...
Posted by Michael Wonder on 20 Sep 2021
Aveo Oncology announces ficlatuzumab granted fast track designation by the U.S. FDA for the treatment of relapsed or recurrent head and neck squamous cell carcinoma
20 September 2021 - Aveo Oncology today announced that the U.S. FDA has granted fast frack designation to ficlatuzumab for the ...