18 November 2020 - Approval based on four pivotal studies showing Exparel reduced pain scores and opioid use following surgery. ...
18 November 2020 - Omeros Corporation announced that it has completed the rolling submission of its biologics license application to ...
3 September 2020 - Knight Therapeutics Inc. announced filing of the supplement to a new drug submission (SNDS) of Nerlynx ...
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
18 November 2020 - UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the ...
18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...
18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...
17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval. ...
17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...
17 November 2020 - First once-monthly risperidone long-acting injectable used in the treatment of schizophrenia. ...
17 November 2020 - Only biologic approved in Canada to treat severe asthma with type 2 / eosinophilic phenotype, or oral ...
17 November 2020 - ViiV Healthcare today announced that the US FDA has granted breakthrough therapy designation for long-acting, injectable cabotegravir ...
18 November 2020 - The reference product rights holder contends that Centus has not provided complete information about its manufacturing ...
17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...
16 November 2020 - TRACON Pharmaceuticals today announced its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug ...