Anktiva NHS access has no NICE recommendation behind it. The medicine holds a UK licence, but NICE ended its appraisal in June 2026 because ImmunityBio did not submit evidence.
Anktiva NHS Access: Can UK Patients Get It for Bladder Cancer?
read more
Regulatory
The National Priority Voucher: Inside the FDA’s Shortest Review Pathway
Last updated: 15 October 2026. Programme facts checked against FDA sources on that date. A national priority voucher can cut an FDA drug review from around ten months to one or two. The Commissioner’s National Priority Voucher (CNPV) is an FDA pilot programme rather...
Icotrokinra NHS Access: Will the Oral Psoriasis Pill Reach Patients?
Icotrokinra NHS access has no public timetable. Where the MHRA, NICE and J&J stand on the oral psoriasis pill as of 14 October 2026.
When Familiar Is Not Documented: Mandatory GRAS and Traditional Botanicals
Longan was a familiar food in the home I grew up in. It was a tasty summer fruit we ate in southern China, much like an American family might think of mango. Years later, when I started making beverages in St. Louis, I used longan in a hydration drink, well before FDA...
A Regulatory Playbook for SaMD and Digital Health
Six decisions that shape FDA readiness for software as a medical device and connected digital health products A software team can build a compelling product and still reach the submission stage with a fundamental problem: the evidence supports a narrower claim than...
Will the NHS Offer Atezolizumab for dMMR Colon Cancer?
The FDA approved atezolizumab for dMMR colon cancer on 8 October 2026. NICE has set no date, and LSDN found no UK licence yet.
FDA Clears First Glioma PET Imaging Drug After 2025 Rejection
The Food and Drug Administration has approved Pixclara, a glioma PET imaging drug from Telix Pharmaceuticals. Telix announced the decision in its approval announcement on 14 September 2026. The active ingredient is floretyrosine F 18, also written as 18F-FET. Telix...
Why AI Governance in Life Sciences Can’t Wait for Regulatory Clarity
The regulatory picture for AI governance in life sciences just got more confusing, not less. In June 2026, the European Union's Digital Omnibus package pushed back the EU AI Act's compliance deadline for stand-alone high-risk AI systems from August 2026 to December...
Cabozantinib Salt Form Wins FDA Approval Past Malate Patents
A new cabozantinib salt form has cleared the US Food and Drug Administration. Handa Oncology announced on 11 September 2026 that the agency had granted final approval to OMCAZIO (cabozantinib) capsules. The product sits outside the patent estate Exelixis has spent...
Lenacapavir NHS Access Stalls as NICE Rejects Twice-Yearly PrEP
Lenacapavir NHS access for HIV prevention has stalled at the first hurdle. NICE published draft guidance on 9 September 2026. It does not recommend the twice-yearly injection as pre-exposure prophylaxis in England. The draft does not question whether the medicine...
The GLP-1 Divide: Who Gets the Best Weight-Loss Drugs, and Who Pays for It
A patient arrived on my ward recently with a story I have heard so many times it no longer surprises me. Her blood sugar had crept back into the danger zone, her blood pressure was climbing, and the weight she had lost over the previous year was almost all back. The...
Section 232 Pharma Tariffs: What Changes on 29 September
On 29 September 2026, Section 232 pharma tariffs reach every company not named in Annex III. The default rate is 100 per cent ad valorem. It applies to patented finished medicines and their associated ingredients. That means active pharmaceutical ingredients and key...
Camizestrant Approval Makes ctDNA Progression a Regulatory Endpoint
The camizestrant approval granted by the US Food and Drug Administration on 4 September 2026 sets an oncology precedent. It is the first US clearance of a cancer therapy triggered by a resistance mutation found in blood. The agency made that claim itself. The trigger...
CBD Vaping: When Product Innovation Outpaces the Science
Early research offers insight, but major gaps remain in understanding long term respiratory effects The rapid rise of CBD vaping products has outpaced the science and regulatory frameworks needed to fully understand their health implications. While early research...
Alexander Disease Treatment Approved: What It Means for UK Access
The United States Food and Drug Administration has approved the first Alexander disease treatment. Zanvastro (zilganersen) was cleared on 3 September 2026 for paediatric and adult patients. Ionis Pharmaceuticals developed the antisense oligonucleotide. The decision...
Huntington Gene Therapy Submission Reaches FDA and MHRA
uniQure filed for regulatory approval of its Huntington’s disease gene therapy on 2 September 2026. The Huntington gene therapy submission went to two agencies. One is the US Food and Drug Administration. The other is the UK Medicines and Healthcare products...
Avacopan UK Suspension Follows Retracted Trial Data
The avacopan UK suspension took effect on 1 September 2026. The Medicines and Healthcare products Regulatory Agency stopped supply of the medicine to new patients that day. It also signalled its intention to revoke the UK marketing authorisation on 1 March 2027. The...
Brepocitinib Dermatomyositis Approval Breaks the Steroid-First Pattern
The brepocitinib dermatomyositis approval landed on 27 August 2026. It is the first shift in a treatment field that has barely moved in decades. The US Food and Drug Administration cleared LISRAYA, an oral dual TYK2 and JAK1 inhibitor, for adults with dermatomyositis....