Blog
RSS FeedPosted by Michael Wonder on 01 Dec 2025
Vanda Pharmaceuticals provides regulatory update on tradipitant for motion sickness
28 November 2025 - Vanda Pharmaceuticals today announced updates regarding tradipitant for motion sickness. ...
Posted by Michael Wonder on 01 Dec 2025
Lilly lowers the price of Zepbound (tirzepatide) single-dose vials
1 December 2025 - Eli Lilly announced Zepbound (tirzepatide) single dose vials will now be available at lower prices on LillyDirect, ...
Posted by Michael Wonder on 28 Nov 2025
Utilisation of real world evidence in regulatory approvals for multiple myeloma therapies
27 November 2025 - Multiple myeloma is a rare, incurable haematologic malignancy that demands ongoing innovation in treatment approaches given frequent ...
Posted by Michael Wonder on 28 Nov 2025
Celltrion receives Health Canada approval for Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg)
27 November 2025 - The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global ...
Posted by Michael Wonder on 27 Nov 2025
Alvotech announces approval of AVT03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area
November 24, 2025 - Alvotech today announced that the European Commission has approved AVT03 as a biosimilar to Prolia and ...
Posted by Michael Wonder on 27 Nov 2025
US FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma
26 November 2025 - BeOne Medicines today announced that the US FDA has accepted and granted priority review to a ...
Posted by Michael Wonder on 26 Nov 2025
FDA grants fast track designation to Cothera Bioscience’s zotiraciclib for treatment of recurrent high grade glioma with IDH1/2 mutations
26 November 2025 - Cothera Bioscience today announced that the US FDA has granted fast track designation to zotiraciclib (ZTR/TG02) for ...
Posted by Michael Wonder on 26 Nov 2025
Novo Nordisk files for FDA approval of a higher dose of Wegovy injection 7.2 mg
26 November 2025 - Today, Novo Nordisk announced the submission of an supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 26 Nov 2025
Ascendis announces extension of FDA review period for TransCon CNP (navepegritide) for children with achondroplasia
25 November 2025 - PDUFA goal date extended by three months to 28 February 2026. ...
Posted 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
Dupixent (dupilumab) approved as the first targeted medicine in the European Union in over a decade for chronic spontaneous urticaria
25 November 2025 - Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared ...
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 ...