Latest Fda News

Telix Pharmaceuticals has initiated a US$550 million convertible bonds offering to refinance existing 2029 bonds and support general corporate purposes, securing low-cost, non-dilutive financing with a conversion premium above current share price.

PainChek has secured a landmark agreement with Sabra Health Care REIT to deploy its AI-powered pain assessment across up to 20,000 beds in North America, marking a pivotal step in its US expansion.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

EMVision Medical Devices has ramped up recruitment in its pivotal FDA trial across eight hospitals and is nearing results from multiple pre-hospital studies, all while bolstering its cash position with a $3.8 million R&D tax refund and $6.6 million in grant funding.

Telix Pharmaceuticals and Regeneron have entered a strategic collaboration to co-develop next-generation radiopharmaceutical therapies, with Telix receiving a $40 million upfront payment and potential milestones exceeding $2 billion.

Lumos Diagnostics Holdings Limited (ASX: LDX) has opened a Share Purchase Plan (SPP) offering eligible shareholders the chance to invest up to A$30,000 at A$0.225 per share, accompanied by free options. The SPP aims to raise up to A$2 million and closes on 24 April 2026.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) has received FDA Investigational New Drug clearance to initiate a pivotal clinical trial of its cell therapy Ryoncil in children with Duchenne Muscular Dystrophy, aiming to address inflammation-driven disease progression.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals has broadened availability of DAYBUE STIX, a new FDA-approved powder formulation of trofinetide for Rett syndrome, in the US. Early caregiver feedback and expert consensus highlight its potential role in personalised patient care.

Lumos Diagnostics has entered a three-year contract manufacturing agreement with Micro-Pak to produce the Mold Analyzer system, marking a transition from development to commercial-scale manufacturing with an initial US$250,000 purchase order.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.