Blog
RSS FeedPosted by Michael Wonder on 02 Dec 2025
Merck granted fast track designation by the US FDA for MK-2214 for the treatment of Alzheimer's disease
1 December 2025 - MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau. ...
Posted by Michael Wonder on 02 Dec 2025
Ionis receives US FDA breakthrough therapy designation for olezarsen for severe hypertriglyceridaemia
1 December 2025 - On track to submit supplemental new drug application by end of year. ...
Posted by Michael Wonder on 01 Dec 2025
Sound Pharmaceuticals receives FDA breakthrough therapy designation for SPI-1005 to treat Meniere’s disease
1 December 2025 - Sound Pharmaceuticals is pleased to announce that the FDA has granted its investigational new drug, SPI-1005, breakthrough ...
Posted by Michael Wonder on 01 Dec 2025
Cullinan Therapeutics receives FDA fast track designation for CLN-049, a novel FLT3xCD3 T cell engager, in relapsed/refractory acute myeloid leukemia
1 December 2025 - Cullinan Therapeutics today announced that the US FDA has granted fast track designation to CLN-049 for ...
Posted 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 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 ...