Government
Every published round US Food and Drug Administration took part in, and every parcel of existing shares it bought off another holder. Deals we hold but haven't published yet are not counted.
Companies US Food and Drug Administration has backed in a published round, and companies whose existing shares it bought off another holder.
| Company | What it does | First invested | Rounds | Led |
|---|---|---|---|---|
| No portfolio companies recorded yet. | ||||
Fund closes reported for US Food and Drug Administration, as distinct from the investments it has made.
Companies US Food and Drug Administration has backed that another company then bought. An exit for the holding, not a deal US Food and Drug Administration did.
Stories naming US Food and Drug Administration. Where several outlets covered the same round, they are bundled under whichever ran the fullest account.
America's medicines regulator has approved Currus Biologics to begin human trials of CUR-001, its solid-tumour CAR T-cell therapy combination, with dosing expected from early 2027.
Australian biotech Currus Biologics has won US regulator clearance to begin human testing of its lead cancer therapy, CUR-001; the company's backers include Brandon Capital, Main Sequence and Uniseed.
OncoSil Medical has raised $5.6m from three large existing shareholders to fund overseas and domestic launches of its radiation therapy, after winning TGA and FDA clearances for pancreatic and bile duct cancer use.
Mesoblast has finished dosing all 350 patients in its phase 3 trial of rexlemestrocel-L for degenerative disc disease, with data due mid-2027 and a possible US biologics application to follow.
Australian device maker OncoSil Medical has won US FDA humanitarian exemption approval for its targeted radiation treatment for unresectable distal bile duct cancer, opening a path to American commercialisation in financial year 2027.
The US medicines regulator has granted Fast Track designation to Aravax's peanut-allergy immunotherapy PVX108, easing its development path; the Melbourne-based biotech expects Phase 2 data later in 2026.
Melbourne biotech Denteric has won US regulatory clearance to trial GPV381, a vaccine-style therapy targeting the bacteria behind gum disease, with a Phase 2 study in the United States to follow.
Cardiac device maker EBR Systems has won US regulator clearance for its leadless heart-failure therapy, clearing the way for staged commercial release later in 2025 and broader distribution in 2026.
Profile of OncoRes Medical CEO Katharine Giles, tracing her path from surgeon to venture investor and her leadership of the Western Australian medtech firm developing a handheld device for precise breast cancer surgery.
Brisbane medtech Convergence Medical has closed a $5 million Series A with US backer Avicella Capital, valuing the surgical robot developer at $30 million as it prepares to commercialise and enter the US market.
Cytopia founder Andrew Wilks and Chris Burns won the 2024 Prime Minister's Prize for Innovation for inventing momelotinib, a rare blood-cancer drug the US FDA approved in 2023.
Mesoblast says the US FDA has confirmed its clinical data now supports refiling the remestemcel-L biologics application for pediatric patients, with resubmission planned next quarter; shares rose on the announcement.
The federal MRFF has granted $50 million to the Artificial Heart Frontiers Program, a Monash-led consortium including BiVACOR, to advance a total artificial heart; the team earlier received $1 million in 2021.
Also @AuManufacturing
Manufacturing briefs: milk company results, a biotech shelving US studies, a rare earths R&D incentive, wind zone consultations, land tax anger, a big battery, a food tech centre launch, and a CEO appointment.
Roundup of manufacturing news: Namoi Cotton agrees a takeover scheme with Louis Dreyfus, Bio-Gene receives an R&D tax payment, SPEE3D and NIOA appoint executives, and Cicada opens workshop applications.
Brisbane surgical-robotics startup Convergence Medical wins a US regulator's fast-track designation for its arthroscopic robot; the piece recalls two recent raises totalling $3 million and a new chief medical officer hire.
Melbourne biotech Certa Therapeutics reported encouraging Phase 2 results for its scleroderma drug FT011 at a US rheumatology meeting, with safety confirmed and a pivotal trial planned.
Australian biotech Certa Therapeutics reports Phase 2 scleroderma trial results for FT011 at a US rheumatology meeting, showing efficacy and safety, with a pivotal study planned.
AirXpanders wins US regulator clearance for an improved film material in its breast reconstruction device, reporting sales hires and clinic conversions as its American rollout begins ahead of schedule.
Sunshine Heart's C-Pulse heart-assist device has been implanted in a sixth trial patient, with Pennsylvania State University performing its first such procedure under US regulatory approval.
Sunshine Heart says the US FDA approved a reimbursement category for its C-Pulse heart assist trial, opening Medicare reimbursement; it retained Quorum Consulting and expects patient enrollment at six US institutions in late 2008.