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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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) ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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Marinus Pharmaceuticals announces FDA acceptance for filing and priority review of new drug application for ganaxolone in CDKL5 deficiency disorder

20 September 2021 - FDA indicated that it is not currently planning to hold an advisory committee meeting for the ...

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FDA approves first biosimilar to treat macular degeneration disease and other eye conditions

17 September 2021 - The U.S. FDA today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the ...

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