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Home » Topics » Regulatory » TGA

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

June 3, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Nibec stock soars 30% on $435M peptide deal with US biotech

May 29, 2025
By Marian (YoonJee) Chu
No Comments
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.
Read More
World with digital overlay
MedCon 2025

Differences in risk classification schema not necessarily a bar on reliance

April 24, 2025
By Mark McCarty
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.
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Australia flag with microscope, test tubes

TGA feeling the Brussels effect in IVD risk classification draft

March 31, 2025
By Mark McCarty
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.
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Map of Europe, Medical Device Regulation (MDR) text

EU MDR backlog could create an opportunity for Australia

March 7, 2025
By Tamra Sami
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.
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Australia’s TGA rejects Eisai’s Leqembi again

March 4, 2025
By Tamra Sami
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.
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Red wooden approved stamp

TGA clears CSL’s garadacimab to prevent hereditary angioedema

Feb. 4, 2025
By Tamra Sami
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.
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Female researcher wearing mask and safety glasses holding dropper

APACMed sees urgent need to harmonize regs for LDTs across APAC

Jan. 31, 2025
By Tamra Sami
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.
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Flag of Australia, sky background

TGA posts draft guidance for non-mandatory application audits

Jan. 29, 2025
By Mark McCarty
Australia’s Therapeutic Goods Administration posted a draft guidance dealing with non-mandatory audits for premarket applications, which says that a transcatheter aortic valve replacement device that has been approved by the U.S. FDA may not be subject to such an audit.
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Red wooden approved stamp

TGA clears CSL’s garadacimab to prevent hereditary angioedema

Jan. 28, 2025
By Tamra Sami
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.
Read More
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