27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...
31 March 2021 - Evive is the first Chinese biologics company to advance a novel biologic product from pre-clinical studies to ...
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
23 November 2020 - Merck today announced the company has submitted applications to the U.S. FDA and EMA for licensure of ...
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 ...
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 ...