Blog
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 21 Nov 2025
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics initiate rolling submission of new drug application to US FDA for zipalertinib for treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
20 November 2025 - Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics today announced the companies have initiated the rolling submission ...
Posted by Michael Wonder on 20 Nov 2025
Nuvalent announces FDA acceptance of new drug application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1 positive NSCLC
19 November 2025 - Nuvalent today announced the US FDA has accepted for filing its new drug application for zidesamtinib, ...
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
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
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
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 18 Nov 2025
Vasa Therapeutics granted FDA fast track designation for VS-041, a novel investigational treatment of heart failure with preserved ejection fraction
18 November 2025 - Vasa Therapeutics today announced that the US FDA has granted fast track designation to its lead investigational ...
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
Henlius and Organon announce US FDA approval of Poherdy (pertuzumab-dpzb), the first Perjeta (pertuzumab) biosimilar in the US
17 November 2025 - Shanghai Henlius Biotech and Organon today announced that the US FDA has approved the biologics license application ...
Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA ...
Posted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...