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RSS FeedPosted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
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 ...
Posted by Michael Wonder on 20 Sep 2021
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 ...
Posted by Michael Wonder on 20 Sep 2021
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 ...
Posted by Michael Wonder on 20 Sep 2021
FDA clears first technology to distinguish between bacterial and viral infections using the body’s immune response – the MeMed BV test and MeMed key platform
20 September 2021 - MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial ...
Posted by Michael Wonder on 20 Sep 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for LAG-3-blocking antibody relatlimab and nivolumab fixed dose combination as treatment for patients with unresectable or metastatic melanoma
20 September 2021 - The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination ...
Posted by Michael Wonder on 20 Sep 2021
AbbVie submits regulatory application to FDA for risankizumab-rzaa (Skyrizi) for the treatment of patients 16 years and older with moderate to severe Crohn's disease
20 September 2021 - In three pivotal Phase 3 trials, risankizumab-rzaa demonstrated significant improvements in clinical remission and endoscopic response as ...
Posted by Michael Wonder on 20 Sep 2021
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain
19 September 2021 - Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor ...