Blog
RSS FeedPosted by Michael Wonder on 13 Apr 2026
Ifinatamab deruxtecan granted priority review in the US for adult patients with previously treated extensive-stage small cell lung cancer who experienced disease progression on or after platinum-based chemotherapy
13 April 2026 - Based on results from IDeate-Lung01 Phase 2 trial, with support from IDeate-PanTumor01 Phase 1/2 trial. ...
Posted by Michael Wonder on 11 Apr 2026
FDA approves updated Vabysmo label to extend treatment for macular oedema following retinal vein occlusion beyond six months
9 April 2026 - Genentech has received US FDA approval of Vabysmo (faricimab-svoa) for the treatment of macular oedema due to ...
Posted by Michael Wonder on 10 Apr 2026
Celltrion’s ADC candidate CT-P71 wins FDA fast track in urothelial cancer
9 April 2026 - Celltrion announced Thursday that the US FDA has granted fast track designation to its antibody-drug conjugate ...
Posted by Michael Wonder on 10 Apr 2026
Foundayo (orforglipron), Lilly's new oral GLP-1 pill for weight loss, now available in the US
9 April 2026 - Foundayo, the only GLP-1 pill for weight loss that can be taken any time of day ...
Posted by Michael Wonder on 07 Apr 2026
NextCure receives fast track designation for SIM0505 (CDH6 ADC) in ovarian cancer
7 April 2026 - NextCure today announced that the US FDA has granted fast track designation for SIM0505 for the ...
Posted by Michael Wonder on 07 Apr 2026
Climb Bio announces FDA fast track designation for budoprutug for the treatment of primary membranous nephropathy
7 April 2026 - Climb Bio today announced that the US FDA has granted fast track designation to budoprutug, the company’s ...
Posted by Michael Wonder on 07 Apr 2026
Nuvalent announces submission of new drug application to FDA for neladalkib in TKI pre-treated advanced ALK positive NSCLC
7 April 2026 - New drug application based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 ...
Posted by Michael Wonder on 07 Apr 2026
FDA approves first generic dapagliflozin tablets
7 April 2026 - FDA approves multiple generics of Farxiga. ...
Posted by Michael Wonder on 03 Apr 2026
Context Therapeutics announces CTIM-76 receives FDA fast track designation for the treatment of platinum-resistant ovarian cancer
2 April 2026 - Context Therapeutics today announced that the US FDA has granted fast track designation to CTIM-76, a ...
Posted by Michael Wonder on 02 Apr 2026
Cocrystal Pharma receives FDA fast track designation for CDI-988 for norovirus infection treatment and preventive
2 April 2026 - Cocrystal Pharma announces that the US FDA has granted fast track designation to its oral, direct-acting ...
Posted by Michael Wonder on 02 Apr 2026
Eylea HD (aflibercept) approved by FDA as first and only injectable anti-VEGF with dosing intervals up to 5 months for wet age-related macular degeneration and diabetic macular oedema
2 April 2026 - Regeneron Pharmaceuticals today announced that the US FDA has approved the extension of dosing intervals for Eylea ...
Posted by Michael Wonder on 02 Apr 2026
Fore Biotherapeutics receives breakthrough therapy designation for plixorafenib
1 April 2026 - Fore Biotherapeutics today announced that the US FDA has granted breakthrough therapy designation to plixorafenib for the ...
Posted by Michael Wonder on 02 Apr 2026
Pasithea Therapeutics announces grant of fast track designation by FDA to PAS-004 for treatment of neurofibromatosis type 1 associated plexiform neurofibromas causing significant morbidity
1 April 2026 - Pasithea Therapeutics today announced that the US FDA has granted fast track designation to PAS-004 for ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions
1 April 2026 - Foundayo, Lilly's second FDA approved obesity medicine, will be available via LillyDirect with free home delivery, ...
Posted by Michael Wonder on 01 Apr 2026
Vertex announces US FDA approval for label extensions of Alyftrek and Trikafta, expanding availability of these medicines to ~95% of all people with CF in the United States
1 April 2026 - Vertex Pharmaceuticals today announced the US FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the ...