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RSS FeedPosted by Michael Wonder on 26 Aug 2025
Repatha now indicated for adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C
25 August 2025 - Amgen today announced that the US FDA has broadened the approved use of Repatha (evolocumab) to include ...
Posted by Michael Wonder on 21 Aug 2025
Dawnzera (donidalorsen) approved in the US as first and only RNA targeted prophylactic treatment for hereditary angioedema
21 August 2025 - Offers longest dosing option for hereditary angioedema, with dosing every 4 or 8 weeks. ...
Posted by Michael Wonder on 20 Aug 2025
PTC Therapeutics receives complete response letter for vatiquinone NDA
19 August 2025 - PTC Therapeutics announced today that the US FDA has issued a complete response letter related to ...
Posted by Michael Wonder on 17 Aug 2025
Wegovy approved in the US for the treatment of MASH
15 August 2025 - Novo Nordisk today announced that the US FDA has approved an additional indication for Wegovy (semaglutide ...
Posted by Michael Wonder on 16 Aug 2025
FDA approves first immunotherapy for recurrent respiratory papillomatosis
14 August 2025 - Today, the US FDA approved Papzimeos (zopapogene imadenovec-drba), a first of its kind non-replicating adenoviral vector-based immunotherapy ...
Posted by Michael Wonder on 15 Aug 2025
Thermo Fisher receives FDA approval for NGS based companion diagnostic for new non-small cell lung cancer treatment
11 August 2025 - Thermo Fisher Scientific has received approval from the US FDA for its Oncomine Dx Target Test as ...
Posted by Michael Wonder on 12 Aug 2025
FDA approves Brinsupri (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis, a serious, chronic lung disease
12 August 2025 - Brinsupri, a first in class DPP1 inhibitor targeting neutrophilic inflammation, is available by prescription through a comprehensive ...
Posted by Michael Wonder on 08 Aug 2025
FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
8 August 2025 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 08 Aug 2025
FDA approves expanded indication for Avtozma (tocilizumab-anoh) intravenous formulation in cytokine release syndrome
6 August 2025 - Approval of Avtozma (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and paediatric patients aged ...
Posted by Michael Wonder on 06 Aug 2025
FDA grants accelerated approval to dordaviprone for diffuse midline glioma
6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...
Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...
Posted by Michael Wonder on 01 Aug 2025
FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors
31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...
Posted by Michael Wonder on 01 Aug 2025
Lenz Therapeutics announces US FDA approval of Vizz for the treatment of presbyopia
31 July 2025 - Vizz samples and product availability in the US expected as early as October 2025. ...
Posted by Michael Wonder on 01 Aug 2025
Novartis twice yearly Leqvio (inclisiran) receives FDA approval for new indication enabling first-line use
31 July 2025 - 4 out of 5 atherosclerotic cardiovascular disease patients do not reach guideline-recommended LDL-C target, reinforcing urgent need ...
Posted by Michael Wonder on 01 Aug 2025
US FDA approves new Biktarvy indication for people with HIV who are treatment experienced and restarting antiretroviral treatment
30 July 2025 - Gilead Sciences today announced that the US FDA has granted a new approval for a novel ...