8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage ...
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
9 November 2020 - Regulatory submissions based on positive data from Phase 3 FIDELIO-DKD trial recently published in the New England ...
27 October 2020 - Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as ...
19 October 2020 - In three pivotal Phase 3 studies, Rinvoq met co-primary and all secondary endpoints in adult and adolescent ...
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults ...
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
26 August 2020 - The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as Idefirix ...
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
18 August 2020 - The EMA has published a draft agenda for this week's CHMP meeting (written procedure). ...
28 July 2020 - BioMed Valley Discoveries announces the receipt of fast track designation from the US FDA for investigation of ...
22 June 2020 - Senior officials from the European Commission, EMA and the United States FDA held their 2020 bilateral ...
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...