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Jul 10, 2026
Australian and US regulators have warned about sexual enhancement and honey products containing undeclared prescription medicines, prompting recalls and safety alerts. UK regulators also caution about underreported drug-herb interactions and herb-induced liver injury.
Jul 09, 2026
OS Therapies achieved FDA, MHRA, EMA and TGA alignment on the Phase 3 design for OST-HER2 in osteosarcoma. The confirmatory trial must start before BLA grant and is expected in Q3 2026.
May 16, 2026
The TGA warned about the risk of homicidal ideation associated with atomoxetine in paediatric patients and published its February 2026 Product Information safety updates. The updates cover multiple medicines with changes to contraindications, warnings and adverse effects. Nearly one in five Australians took a prescription psychiatric drug in 2023-24.
Jun 14, 2026
Multiple health product recalls have been announced, including a prescription cholesterol medication for dissolution issues and dietary supplements containing undeclared erectile dysfunction drugs Tadalafil and Sildenafil. The FDA and international regulators warn of potential health risks.
Jun 10, 2026
Onco-Innovations has begun scaling production of A83B4C63, the API in its lead cancer drug ONC010, to kilogram quantities at Dalton Pharma Services' Toronto facility to support IND-enabling studies. The company's subsidiary Inka Health signed AI research agreements with AstraZeneca and GlaxoSmithKline, and plans a first-in-human study in 2026 pending a pre-IND meeting with the FDA.
May 04, 2026
Cynata raised $1.5 million through a placement at $0.25 a share ahead of Phase 3 osteoarthritis and Phase 2 aGvHD trial readouts due in May and June 2026. Its aGvHD study has completed the 100-day primary evaluation period for all 65 participants.
Apr 30, 2026
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Mar 15, 2026
Regulatory incentives for rare disease treatments, including market exclusivity and development subsidies, are spurring pharmaceutical innovation across the US, Europe, Japan, and Australia, with multiple companies advancing therapies for conditions affecting limited patient populations.
Mar 13, 2026
Junshi Biosciences reported total revenue of approximately RMB2,498 million in 2025, a 28% increase year-over-year, driven by toripalimab sales growth. Absci Corporation announced it will report fourth quarter and full year 2025 financial results on March 24, 2026.
Mar 02, 2026
Australian regulators confirmed counterfeit GLP-1 products contain no active ingredients, while U.S. authorities escalate enforcement against compounded weight-loss drugs as Novo Nordisk sues telehealth company Hims & Hers.
