TGA

AI, remote care drive new models for Australian medtech

Tue, 26 May 2026 11:00:00 -0400

Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20.

Henlius gains Australian trial clearance for HLX-3902

Fri, 22 May 2026 09:00:00 -0400

Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors.

Scribe’s STX-1150 for hypercholesterolemia cleared for clinic

Fri, 22 May 2026 09:00:00 -0400

Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand.

AI, remote care drive new models for Australian medtech

Thu, 21 May 2026 12:00:00 -0400

Henlius’ HLX-48 for solid tumors cleared for clinic in Australia

Thu, 14 May 2026 09:00:00 -0400

Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors.

Pricing standoff leaves Australian patients in limbo

Tue, 21 Apr 2026 12:00:00 -0400

A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.

Pricing standoff leaves Australian patients in limbo

Wed, 15 Apr 2026 12:00:00 -0400

Ibio’s IBIO-600 cleared to enter clinic in Australia for obesity

Thu, 09 Apr 2026 09:00:00 -0400

Ibio Inc. has received clinical trial notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA), as well as Human Research Ethics Committee approval, for IBIO-600, enabling the initiation of a first-in-human trial in Australia.

Alltrna’s AP-003 cleared for trials for stop codon disease

Wed, 01 Apr 2026 09:00:00 -0400

Alltrna has obtained approval in Australia to initiate a phase I trial of AP-003 in healthy volunteers under Australia’s TGA clinical trial notification scheme. AP-003 is a chemically modified, engineered transfer RNA (tRNA) oligonucleotide encapsulated in a clinically validated, liver-directed lipid nanoparticle.

Ovid’s KCC2 direct activator OV-4071 cleared for clinic

Thu, 19 Mar 2026 09:00:00 -0400

Ovid Therapeutics Inc. has announced plans to initiate a phase I study of OV-4071, an oral, direct activator of potassium-chloride cotransporter 2 (KCC2), having received Australian Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) acknowledgement from Australia’s TGA.

Australia publishes first clinical practice guideline for psychedelics

Tue, 17 Mar 2026 12:00:00 -0400

Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.

Australia launches world-first pediatric mRNA brain cancer trial

Tue, 24 Feb 2026 11:00:00 -0500

A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors.

Australia launches world-first pediatric mRNA brain cancer trial

Fri, 13 Feb 2026 12:00:00 -0500

A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in combination with the Australian Government and philanthropic donors, is the first multisite pediatric study to evaluate individualized mRNA vaccines designed specifically for each child's cancer.

TGA considers a policy dealing with device shortages

Mon, 12 Jan 2026 11:00:00 -0500

The COVID-19 pandemic amplified concerns over medical device shortages, prompting the U.S. FDA to develop guidance on the topic in November 2023. Australia’s Therapeutic Goods Administration is eyeing a guidance to address the very same problem, although the agency seems wary of whether to formally develop a guidance on device shortages.

TGA eyes do-over for conformity assessment procedures

Mon, 05 Jan 2026 11:00:00 -0500

Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.

White House steps in on preemption of state AI law

Fri, 19 Dec 2025 11:00:00 -0500

The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.

TGA updates ad guidelines to include social media

Wed, 12 Nov 2025 11:00:00 -0500

Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.

Digital mental health concerns on tap at FDA, TGA

Tue, 14 Oct 2025 12:00:00 -0400

Digital mental health tools are popping up with some regularity lately, but both Australia’s Therapeutic Goods Administration and the U.S. FDA have enough concerns about these products that they are taking a closer look at their risks and benefits.

TGA casts a baleful glance at medical scribes

Tue, 19 Aug 2025 12:00:00 -0400

Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.

TGA feels the Brussels effect with adoption of EU combo products guideline

Mon, 21 Jul 2025 12:00:00 -0400

Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.

UDI mandates kick in for devices in Australia

Mon, 07 Jul 2025 12:00:00 -0400

Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.

TGA files court action against Philips over CPAP foam controversy

Mon, 09 Jun 2025 12:00:00 -0400

Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand.

Nibec stock soars 30% on $435M peptide deal with US biotech

Tue, 03 Jun 2025 11:00:00 -0400

Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.

Nibec stock soars 30% on $435M peptide deal with US biotech

Thu, 29 May 2025 11:00:00 -0400

Differences in risk classification schema not necessarily a bar on reliance

Thu, 24 Apr 2025 12:00:00 -0400

Regulatory reliance is all the rage of late, but some nations employ a four-tier risk classification scheme while others use a three-tier scheme.

TGA feeling the Brussels effect in IVD risk classification draft

Mon, 31 Mar 2025 12:00:00 -0400

Australia’s Therapeutic Goods Administration floated a draft rule on risk classification for in vitro diagnostics, which does not apply to home use tests, the subject of impending rulemaking.

EU MDR backlog could create an opportunity for Australia

Fri, 07 Mar 2025 11:00:00 -0500

A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.

Australia’s TGA rejects Eisai’s Leqembi again

Tue, 04 Mar 2025 12:00:00 -0500

Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.

TGA clears CSL’s garadacimab to prevent hereditary angioedema

Tue, 04 Feb 2025 12:00:00 -0500

Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.

APACMed sees urgent need to harmonize regs for LDTs across APAC

Fri, 31 Jan 2025 11:00:00 -0500

Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, according to a recent whitepaper developed by APACMed.