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RSS FeedPosted by Michael Wonder on 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
Posted by Michael Wonder on 22 May 2025
Tagrisso approved (with conditions) in Canada for patients with unresectable, stage III EGFR-mutated non-small cell lung cancer
21 May 2025 - Based on LAURA Phase 3 trial results which showed patients who took Targrisso after CRT had ...
Posted by Michael Wonder on 21 May 2025
Belite Bio announces FDA granting of breakthrough therapy designation for tinlarebant for the treatment of Stargardt disease
21 May 2025 - Belite Bio today announced that the US FDA has granted breakthrough therapy designation for tinlarebant for ...
Posted by Michael Wonder on 21 May 2025
FDA takes steps to enhance state importation programs to help lower prescription drug prices
21 May 2025 - The US FDA is continuing to take steps to help state importation programs provide safe, effective and ...
Posted by Michael Wonder on 21 May 2025
New weekly treatment option approved for patients with haemophilia B
21 May 2025 - Final draft guidance published today recommends marstacimab (Hympavzi; Pfizer) for treating severe haemophilia B in patients ...
Posted by Michael Wonder on 21 May 2025
Lilly's Kisunla (donanemab) receives marketing authorisation in Australia for the treatment of early symptomatic Alzheimer's disease
21 May 2025 - The authorisation in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers. ...
Posted by Michael Wonder on 21 May 2025
ICER to assess treatment for smoking cessation
20 May 2025 - Report will be subject of Midwest CEPAC meeting in January 2026; draft scoping document open to ...
Posted by Michael Wonder on 19 May 2025
Trump wants to ‘equalize’ and lower drug prices. Could Canada be impacted?
17 May 2025 - US President Donald Trump has launched a new effort to lower prescription drug prices for Americans ...
Posted by Michael Wonder on 19 May 2025
Zai Lab receives US FDA fast track designation for ZL-1310, a DLL3 targeted antibody drug conjugate, for treatment of extensive stage small cell lung cancer
19 May 2025 - The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung ...
Posted by Michael Wonder on 19 May 2025
ICER publishes protocol for first annual launch price and access report
19 May 2025 - Report to be issued in October 2025. ...
Posted by Michael Wonder on 18 May 2025
MHRA approves guselkumab for Crohn’s disease and ulcerative colitis
16 May 2025 - The MHRA has today approved guselkumab (Tremfya) to treat Crohn’s disease and ulcerative colitis. ...
Posted by Michael Wonder on 17 May 2025
PharmaTher announces FDA extends review period for ketamine; new approval goal date 9 August 2025
16 May 2025 - PharmaTher today announced the US FDA has extended the approval goal date for the review of ...
Posted by Michael Wonder on 16 May 2025
BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%
16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...
Posted by Michael Wonder on 16 May 2025
Amneal receives US FDA approval for Brekiya (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults
15 May 2025 - Product will be available for appropriate patients in the second half of 2025 ...
Posted by Michael Wonder on 16 May 2025
Kaerus Bioscience's lead candidate KER-0193 granted orphan drug designation and rare paediatric drug designation by US FDA for treatment of Fragile X syndrome
14 May 2025 - Kaerus Bioscience today announces that its lead candidate KER-0193 has been granted both orphan drug designation and ...