Blog
RSS FeedPosted by Michael Wonder on 26 Nov 2025
Otsuka Pharmaceutical submits new drug application to US FDA for centanafadine for the treatment of ADHD in children, adolescents, and adults
24 November 2025 - Otsuka today announce the filing of a new drug application with the US FDA for centanafadine, once ...
Posted by Michael Wonder on 26 Nov 2025
FDA approves a new treatment for primary immunoglobulin A nephropathy
25 November 2025 - The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) injection to reduce proteinuria in adults ...
Posted by Michael Wonder on 26 Nov 2025
Eisai completes rolling submission to US FDA for Leqembi Iqlik (lecanemab-irmb) supplemental biologics license pplication as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
25 November 2025 - Eisai and Biogen announced today that Eisai has completed the rolling submission of the supplemental biologics ...
Posted by Michael Wonder on 25 Nov 2025
FDA approves durvalumab for resectable gastric or gastro-oesophageal junction adenocarcinoma
25 November 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as ...
Posted by Michael Wonder on 25 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-103, a potential best in class nectin4/TROP2 bispecific antibody drug conjugate, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin
24 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-103, a potential best ...
Posted by Michael Wonder on 24 Nov 2025
Novartis receives FDA approval for Itvisma, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy
24 November 2024 - Novartis today announced that the US FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of children ...
Posted by Michael Wonder on 24 Nov 2025
Merck takes patient-directed approach to bring innovation to the treatment of rare neuromuscular disorder, generalised myasthenia gravis
24 November 2025 - Merck today announced the FDA has granted fast track designation for cladribine capsules for the treatment of generalised ...
Posted by Michael Wonder on 21 Nov 2025
Sangamo Therapeutics announces FDA acceptance of BLA rolling submission request for ST-920 in Fabry disease
21 November 2025 - Sangamo Therapeutics today announced that the US FDA has accepted Sangamo’s request for a rolling submission and ...
Posted 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, ...