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MHRA touts uptick in approvals in 2025-2026 annual report

Mon, 20 Jul 2026 00:00:00 +0000

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs than the prior year, removing a record number of illegal drugs from circulation, and taking steps to advance the regulation of artificial intelligence (AI) in healthcare.

Study: China outpaces the US in cancer approvals, lags behind on first approvals

Mon, 20 Jul 2026 00:00:00 +0000

While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first-in-class drugs and tended to approved products faster and earlier than China, according to a recent study published in Health Affairs.

Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools

Mon, 20 Jul 2026 00:00:00 +0000

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).

Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B

Mon, 20 Jul 2026 00:00:00 +0000

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, and more

Fri, 17 Jul 2026 00:00:00 +0000

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA staff raised concerns internally about conflicts of interest ahead of a panel on peptides next week, a top Democrat is seeking an investigation into the effects of the DOGE cuts on FDA, and the agency’s acting commissioner backtracked on some policies issued by his predecessor.

Industry wants more clarity on NGS for assessing gene therapy safety

Fri, 17 Jul 2026 00:00:00 +0000

The pharmaceutical industry has largely endorsed the US Food and Drug Administration's (FDA) guidance on next-generation sequencing (NGS) for assessing the safety of human gene therapy products. However, they have requested clarification on several points, including off-target data, nomination methods, and additional information on how to assess these products following any manufacturing changes.

Experts: Ending adequate provision would shut down prescription drug ads

Fri, 17 Jul 2026 00:00:00 +0000

The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high costs associated with fully publicizing a drug's safety profile and practical limitations of broadcast advertising, according to experts who spoke to Focus. It could also make such ads hard to understand for many consumers.

Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives

Thu, 16 Jul 2026 00:00:00 +0000

Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any new framework for repurposing drugs does not disincentivize investment or competition and fits within agency’s existing statutory authority.

CDER plans new guidance on AI, electronic safety report submissions, and more

Thu, 16 Jul 2026 00:00:00 +0000

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new topics since the list was last updated in February.