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RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 01 Apr 2026
Scholar Rock resubmits biologics license application to FDA for apitegromab for treatment of children and adults with spinal muscular atrophy
31 March 2026 - Apitegromab biologics license application resubmission includes Catalent Indiana (part of Novo Nordisk) and second US based fill ...
Posted by Michael Wonder on 31 Mar 2026
BridgeBio submits NDA to FDA for BBP-418 for individuals living with LGMD2I/R9
30 March 2026 - Comprehensive submission includes interim Phase 3 FORTIFY data demonstrating BBP-418’s rapid, consistent treatment effect and favourable safety ...
Posted by Michael Wonder on 31 Mar 2026
Praxis Precision Medicines announces FDA acceptance and priority review of new drug application for relutrigine in patients with SCN2A and SCN8A DEEs
30 March 2026 - Praxis Precision Medicines today announced that the US FDA has accepted for priority review its new ...
Posted by Michael Wonder on 31 Mar 2026
Teva gains biosimilar momentum with US FDA approval of Ponlimsi (denosumab-adet) and dual filing acceptance for biosimilar candidate to Xolair (omalizumab)
30 March 2026 - Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the ...
Posted by Michael Wonder on 31 Mar 2026
Zymeworks receives US FDA fast track designation for ZW191, a folate receptor alfa targeting antibody drug conjugate
30 March 2026 - Zymeworks today announced that the US FDA has granted fast track designation to ZW191, an antibody ...
Posted by Michael Wonder on 30 Mar 2026
Elevar Therapeutics announces FDA acceptance for review of new drug application for lirafugratinib as second-line cholangiocarcinoma treatment
30 March 2026 - Elevar Therapeutics today announced that the US FDA has completed its filing review of the new drug ...
Posted by Michael Wonder on 28 Mar 2026
Egetis announces FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 feficiency
27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application ...