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RSS FeedPosted 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 10 Apr 2026
Sanofi becomes market authorisation holder for Nuvaxovid in Canada, expanding COVID-19 vaccine choices for Canadians
9 April 2026 - Nuvaxovid, a non-mRNA COVID-19 vaccine, will be made available in Canada by Sanofi for the fall 2026-2027 ...
Posted by Michael Wonder on 10 Apr 2026
Sobi receives Health Canada approval for Empaveli (pegcetacoplan) for the treatment of C3G and primary IC-MPGN
9 April 2026 - Approval supported by Phase 3 52 week VALIANT study demonstrated reduced proteinuria, stabilsed kidney function and ...
Posted by Michael Wonder on 08 Apr 2026
Apotex strengthens osteoporosis care in Canada with Health Canada's approval of Denoza, a denosumab biosimilar
7 April 2026 - Apotex today announced that Health Canada has approved Denoza (denosumab injection), a biosimilar to Prolia, for its ...
Posted by Michael Wonder on 08 Apr 2026
Ray Therapeutics receives FDA regenerative medicine advanced therapy designation for RTx-015 in retinitis pigmentosa
1 April 2026 - Ray Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to its ...
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 04 Apr 2026
European Commission approves Keytruda (pembrolizumab) plus paclitaxel ± bevacizumab for the treatment of adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma who have received one or two prior systemic treatment regimens
2 April 2026 - Merck announced that Keytruda (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the ...
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
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 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 ...