Browsing Tag
United States Food and Drug Administration
77 posts
OncoSil Medical (ASX: OSL) rallies as FDA decision window opens
OncoSil is rallying into an FDA decision, but its trial was not designed to prove superiority. Can ASX turn clinical promise into sales?
Appili Therapeutics faces funding reset after NIAID terminates VXV-01 contract
Appili Therapeutics faces a funding reset after NIAID ended its VXV-01 contract. Discover what the termination means for APLI investors.
Can potravitug justify Ipsen’s €700m-plus Memo Therapeutics acquisition?
Ipsen is acquiring Memo Therapeutics to secure potravitug, a clinical-stage antibody targeting a serious kidney transplant complication. The structure limits Ipsen’s upfront exposure while placing the larger valuation behind clinical, regulatory and commercial success.
Saluda Medical wins CAP24 FDA approval as ASX:SLD shares rally 22%
Discover how Saluda Medical’s CAP24 FDA approval may expand Evoke adoption, reshape SCS competition and test ASX’s execution. Read the analysis in full.
Why Avacta’s (AVCT) smallest FAP signal could create a much bigger opportunity for pre|CISION
Avacta Group’s latest faridoxorubicin findings suggest pre|CISION may activate effectively even in tumours with minimal FAP expression, potentially widening the platform’s commercial reach while raising the importance of mature progression-free survival data and a development partnership.
Thalia Therapeutics (AIM: THAT) shares jump 17% as Sanmirna deal adds Phase 1 AML asset
Thalia Therapeutics has agreed to acquire Sanmirna Therapeutics and its Phase 1 acute myeloid leukaemia drug miRisten, while raising £2.75 million to fund clinical data expected in 2027.
Avacta targets late-2026 AVA6103 data as AVCT shifts from funding risk to clinical proof
Avacta Group has outlined a catalyst-heavy second half of 2026, with new AVA6000 data, the first AVA6103 clinical results and potential partnering decisions set to test the commercial value of its tumour-activated oncology platform.
The factory is 60% empty. That may be exactly why Aurobindo Pharma (NSE: AUROPHARMA) wants it
Read how Aurobindo Pharma plans to turn Lannett’s underused US factory, ADHD portfolio and CDMO platform into its next growth engine as policy shifts.
Why the RISE UP trial could become a defining test for Agios Pharmaceuticals’ mitapivat strategy
Find out how Agios Pharmaceuticals’ RISE UP trial could shape mitapivat’s sickle cell disease strategy and AGIO stock sentiment.
Why investors are watching Belite Bio after the tinlarebant NDA submission
Find out how Belite Bio’s tinlarebant FDA filing could reshape rare eye disease treatment and investor sentiment today.