Also known as: TGA
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.
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.
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.
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.
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.
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.
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.
