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RSS FeedPosted by Michael Wonder on 21 Nov 2025
FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
21 November 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with ...
Posted by Michael Wonder on 19 Nov 2025
Eylea HD (aflibercept) injection 8 mg approved by FDA for the treatment of macular oedema following retinal vein occlusion and for monthly dosing across approved indications
19 November 2025 - Regeneron Pharmaceuticals today announced that the US FDA has approved Eylea HD (aflibercept) injection 8 mg for ...
Posted by Michael Wonder on 19 Nov 2025
Libtayo (cemiplimab) approved in the European Union as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with high risk of recurrence after surgery and radiation
19 November 2025 - Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
19 November 2025 - Today, the FDA granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
19 November 2025 - Today, the FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
19 November 2025 - Today, the FDA granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) with bortezomib, ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
19 November 2025 - Roche announced today that the European Commission has granted conditional marketing authorisation of Lunsumio (mosunetuzumab) subcutaneous for ...
Posted by Michael Wonder on 19 Nov 2025
FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
19 November 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) for adults with neurofibromatosis type 1 who have ...
Posted by Michael Wonder on 19 Nov 2025
Esperion partner HLS Therapeutics announces approval of Nilemdo for the reduction of LDL-cholesterol in Canadians at risk of cardiovascular disease
18 November 2025 - Esperion today announced that HLS Therapeutics, the Company’s partner in Canada for the development and commercialization ...
Posted by Michael Wonder on 19 Nov 2025
Grifols receives expanded indication for Thrombate III (antithrombin III [human]) label in US, strengthening treatment options for pediatric patients
18 November 2025 - FDA approval was based on submitted data extrapolation from two clinical trials in adult patients addressing critical ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Brinsupri (brensocatib) as the first and only treatment approved for non-cystic fibrosis bronchiectasis in the European Union
18 November 2025 - Brinsupri was reviewed under EMA's accelerated assessment pathway as it is considered of major interest for public ...
Posted by Michael Wonder on 18 Nov 2025
Arrowhead Pharmaceuticals announces FDA approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
18 November 2025 - The FDA approval is based on positive results from the Phase 3 PALISADE study where Redemplo significantly ...
Posted by Michael Wonder on 18 Nov 2025
FDA approves epcoritamab-bysp for follicular lymphoma indications
18 November 2025 - Today, the FDA approved epcoritamab-bysp (Epkinly, Genmab) with lenalidomide and rituximab for relapsed or refractory follicular ...
Posted by Michael Wonder on 18 Nov 2025
Lupron Depot new strength receives Health Canada approval for the treatment of advanced prostate cancer
17 November 2025 - AbbVie announced today that a new 6 month 45 mg Lupron Depot (leuprolide acetate for extended release ...
Posted by Michael Wonder on 18 Nov 2025
High dose regimen of nusinersen receives positive CHMP opinion for the treatment of spinal muscular atrophy
17 November 2025 - Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen ...