Browsing Tag
United States Food and Drug Administration
193 posts
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 ÂŁ2.75 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.
Can Tanner Health’s InStockRx deal turn wasted hospital drugs into a hidden efficiency win?
Find out how Tanner Health and InStockRx are tackling hospital medication waste, pharmacy efficiency and patient access through smarter stewardship.
Is Atara Biotherapeutics quietly preparing for tougher capital allocation choices?
Find out why Atara Biotherapeutics’ board refresh could reshape capital allocation, regulatory strategy and ATRA stock sentiment as investors watch the FDA.
Why multiple system atrophy could become the biggest test of Alterity Therapeutics’ ATH434 strategy
Find out how FDA alignment on ATH434 could reshape Alterity Therapeutics’ Phase 3 strategy and rare neurology investor outlook.
Alterity Therapeutics (ASX:ATH) has FDA clarity, but Phase 3 funding now tests the rally
Alterity has FDA clarity for ATH434. The bigger question is whether ASX:ATH can fund and execute Phase 3 without losing momentum.