Latest Fda News

EBR Systems has secured a significant regulatory milestone as the US Centers for Medicare & Medicaid Services (CMS) initiates a National Coverage Determination (NCD) for its WiSE wireless cardiac pacing system, aiming for approval by early 2027.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Optiscan Imaging has reached the halfway recruitment milestone in its first in-human breast cancer study, advancing its regulatory and commercial ambitions with promising clinical data and expanded trial sites.

Imagion Biosystems has secured FDA clearance to proceed with its Phase 1b/2 trial of the MagSense® HER2 Imaging Agent, targeting improved detection of HER2+ breast cancer. Patient recruitment is expected to start in Q3 2026, marking a crucial step toward commercialisation.

4DMedical launches the CLEAR clinical evidence program to accelerate adoption of its CT:VQ™ imaging technology in the US acute pulmonary embolism market, aiming to expand its addressable market to US$3 billion.

ReNerve has inked an exclusive three-year deal with Hong Kong’s Swedish Trading Company to distribute its nerve repair products across a vast and dynamic healthcare region.

4DMedical has leapfrogged into the European lung health market by acquiring Austrian AI imaging firm contextflow, gaining immediate commercial presence and a CE-marked lung cancer screening solution.

Amplia Therapeutics reported encouraging mature data from its ACCENT pancreatic cancer trial showing improved survival and response rates with narmafotinib. The company raised $27.5 million to fund development and manufacturing scale-up, while discontinuing a parallel trial due to chemotherapy toxicity.

PolyNovo has completed its pivotal US clinical trial report for NovoSorb BTM and adjusted its FDA Premarket Approval submission timeline to late 2026 to incorporate updated regulatory requirements and additional data.

4DMedical has landed a three-year commercial contract with SimonMed Imaging, deploying its CT:VQ™ technology across more than 170 US outpatient centres, marking a significant step in its US market expansion.

Bubs Australia expects FY26 revenue between $105 million and $115 million, with underlying EBITDA forecast at $4 million to $8 million despite external challenges including regulatory delays and increased air freight costs.

Immuron Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, confirming no undisclosed information but pointing to a recent CEO presentation as a possible driver.