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RSS FeedPosted 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 02 Apr 2026
Ultragenyx announces US FDA acceptance of BLA resubmission for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
2 April 2026 - Ultragenyx Pharmaceutical today announced the US FDA has accepted for review the resubmitted biologics license application seeking ...
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 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
Orca Bio announces FDA review extension of BLA for Orca-T for the treatment of haematologic malignancies
1 April 2026 - Orca Bio today announced that the US FDA has extended the review timeline of its biologics license ...
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
FDA approves new high dose regimen of Spinraza (nusinersen) for spinal muscular atrophy
30 March 2026 - The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety ...
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 ...