Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 12 Jan 2024
European Commission approves Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small-cell lung cancer with a KRAS G12C mutation
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
Posted by Michael Wonder on 12 Jan 2024
Health Canada grants priority review status of ViiV Healthcare's new drug submission for cabotegravir long-acting injectable and tablets for prevention of HIV
10 January 2024 - Application is supported by data from the pivotal Phase 2b/3 studies evaluating safety and efficacy of long-acting ...
Posted by Michael Wonder on 11 Jan 2024
Nucala (mepolizumab) approved in China for use in severe asthma with an eosinophilic phenotype
10 January 2024 - Approval based on a separate Phase 3 trial among Chinese patients reinforcing mepolizumab’s efficacy and safety ...
Posted by Michael Wonder on 11 Jan 2024
Arcutis Canada announces Health Canada acceptance of the supplement to a new drug submission for roflumilast 0.3% foam for the treatment of seborrheic dermatitis in individuals 9 years of age and older
8 January 2024 - Supplement to a new drug submission supported by positive Phase 2 and Phase 3 pivotal trial ...
Posted by Michael Wonder on 11 Jan 2024
STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara
10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...
Posted by Michael Wonder on 10 Jan 2024
Leqembi approved for the treatment of Alzheimer's disease in China
9 January 2024 - BioArctic's partner Eisai announced today that Leqembi (lecanemab-irmb) has been approved in China as a treatment for ...
Posted by Michael Wonder on 10 Jan 2024
AARP statement on FDA’s prescription drugs importation approval for Florida
8 January 2024 - AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond issued the following statement ...
Posted by Michael Wonder on 10 Jan 2024
Tivdak supplemental biologics license application accepted for priority review by FDA for patients with recurrent or metastatic cervical cancer
9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK ...
Posted by Michael Wonder on 10 Jan 2024
European Commission approves Pfizer’s Talzenna in combination with Xtandi for adult patients with metastatic castration resistant prostate cancer
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
Posted by Michael Wonder on 09 Jan 2024
Seres Therapeutics announces US FDA fast track designation for SER-155
9 January 2024 - SER-155 Phase 1b placebo controlled Cohort 2 data readout anticipated in third quarter of 2024. ...
Posted by Michael Wonder on 09 Jan 2024
Sellas Life Sciences receives FDA fast track designation for SLS009 for treatment of relapsed/refractory acute myeloid leukaemia
9 January 2024 - Sellas Life Sciences Group today announced that the US FDA has granted fast track designation to SLS009 ...
Posted by Michael Wonder on 09 Jan 2024
Orphan drug label expansions: analysis of subsequent rare and common indication approvals
8 January 2024 - We found that 491 novel orphan drugs were approved between 1990 and 2022. ...
Posted by Michael Wonder on 09 Jan 2024
Astellas provides update on zolbetuximab biologics license application in US
8 January 2024 - Astellas Pharma today announced the US FDA issued a complete response letter on 4 January 2024, ...
Posted by Michael Wonder on 09 Jan 2024
Zevra Therapeutics receives FDA acceptance of resubmission of NDA for arimoclomol as a treatment for Niemann-Pick disease type C
8 January 2024 - Arimoclomol NDA has been assigned a PDUFA action date of 21 June 2024. ...
Posted by Michael Wonder on 08 Jan 2024
Cabaletta Bio receives additional FDA fast track designations for CABA-201 in dermatomyositis and systemic sclerosis
8 January 2024 - Second and third FDA fast track designations for CABA-201, following the systemic lupus erythematosus and lupus ...