Browsing Tag
United States Food and Drug Administration
192 posts
Neuren Pharmaceuticals (ASX: NEU) gains fourth US orphan drug designation for NNZ-2591
Neuren Pharmaceuticals has received United States orphan drug designation for NNZ-2591 in neonatal hypoxic-ischaemic encephalopathy, expanding regulatory incentives for its neurological drug pipeline while a required juvenile animal safety study delays the proposed clinical development programme.
Sun Pharmaceutical (SUNPHARMA) gains US approval for ILUMYA as Q2 profit falls 36%
Sun Pharmaceutical Industries has secured United States regulatory approval to expand ILUMYA into active psoriatic arthritis, strengthening its innovative medicines portfolio. The approval coincides with double-digit quarterly revenue growth but a sharp decline in reported profit, leaving product commercialisation and acquisition integration as important financial tests.
Avacta’s AVA6000 delivers 11.4-month PFS signal as investors await proof from lead drug AVA6103
Avacta Group plc has reported median progression-free survival of 11.4 months in a selected group of salivary gland cancer patients treated with faridoxorubicin, compared with historical benchmarks of six to 6.7 months. The findings strengthen the clinical case for its tumour-targeting technology, but differences between patient populations, a recently completed £12.5 million fundraising and the need for further clinical validation leave important questions for shareholders.
Senores Pharmaceuticals (SENORES) targets 3.2bn annual manufacturing units, yet 50% to 70% utilisation raises a bigger question
Senores Pharmaceuticals Limited has announced ₹43 crore of manufacturing capacity investments across the United States and India, alongside quarterly revenue growth of nearly 25% and improved operating margins. However, the stock's 14.4% decline across two trading sessions has drawn attention to capacity utilisation, cash conversion and the company's ability to commercialise its growing pharmaceutical portfolio.
Glaukos (NYSE: GKOS) targets $1bn in sales. Can Epioxa offset iDose risk?
Glaukos shares surged in after-hours trading after the company raised its 2026 revenue forecast and introduced a US$1 billion sales target for 2027. But the ambitious outlook depends on a successful Epioxa rollout and continued demand for iDose TR, whose Medicare coverage remains under review.
Roche (SIX: ROP) sales rise 7% as pipeline hopes meet a near-record valuation
Roche delivered 7% constant-currency Q3 sales growth and maintained 2026 guidance as newer medicines offset patent erosion. With ROP touching a 52-week high and key medicines still awaiting regulatory decisions, pipeline conversion is becoming the next valuation test.
EBR Systems seeks Australian approval for WiSE wireless heart pacing device after US launch
EBR Systems has submitted its WiSE cardiac pacing system for Australian regulatory inclusion following an earlier priority review determination, potentially opening a second commercial market while the company's United States implant rollout continues at a slower pace than previously anticipated.
Mesoblast (ASX: MSB) reports US$99m cash after stronger Ryoncil sales and lower expenditure
Mesoblast has reported higher year-on-year revenue from its approved cell therapy Ryoncil and a sharp reduction in operating cash expenditure, although sequential sales declined following a stronger June quarter.
America is moving away from synthetic food dyes. Why could Oterra be one of the biggest beneficiaries?
Oterra has installed former Royal Greenland chief Susanne Arfelt Rajamand as Chief Executive Officer as United States food companies accelerate their move away from synthetic dyes. The privately owned ingredients group says its core US business could double within two years, giving its new leader an unusually clear growth opportunity but also a major manufacturing and supply-chain execution challenge.
Stryker invests $400m in CMR Surgical as Versius robot opens new soft-tissue growth market
Stryker invests $400 million in CMR Surgical and gains U.S. rights to Versius. Find out what the robotics alliance could mean for SYK investors.