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BioMarin Fabry Deal: What Does It Get for $70 Million Upfront?
The BioMarin Fabry deal gives the US company exclusive worldwide rights, outside Korea, to an early-stage injectable enzyme therapy. BioMarin announced the licence on 29 October 2026 with GC Biopharma and Hanmi Pharm. The candidate is HM15421/GC1134A, also known as...
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Who Owns Ilofotase Alfa Now? Inside Ambrose’s AM-Pharma Deal
Ilofotase alfa now belongs to Ambrose Healthcare, a UK-headquartered rare disease company. On 20 October 2026, Ambrose said it had acquired 100 per cent of the shares of AM-Pharma. The Dutch company, based in Utrecht, developed the drug. The deal is complete rather...
RNA-LNP Development: Creative Biolabs Links Design, Formulation & Analysis
RNA delivery research is moving beyond conventional lipid nanoparticle (LNP) formulation toward a more systematic understanding of how lipid chemistry, particle organization, and intracellular trafficking influence delivery performance. As researchers confront...
Bepirovirsen NHS Access: Will UK Hepatitis B Patients Get Hibsago?
Bepirovirsen NHS access is undecided, because the drug has no UK marketing authorisation. GSK said the US FDA approved bepirovirsen, branded Hibsago, for chronic hepatitis B on 20 October 2026. NHS patients cannot expect routine access until the MHRA authorises it and...
Pediatric Eye Injuries: Severity, Referral and Permanent Vision Loss
A child's vision is one of their most important developmental assets. Sight shapes how children learn, play, read, and connect with the world around them, and unlike many other aspects of health, vision loss caused by pediatric eye injuries can have consequences that...
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Medical AI Is Getting Better. Why Is Diagnosis Getting Harder?
A radiologic study today rarely arrives alone. It comes wrapped in automated detection flags, quantitative lesion scores, an AI-drafted report, historical imaging, EHR clinical notes, and subspecialty consult requests. What it does not come wrapped in is medical AI...
Stellaromics Expands Pyxa Adoption Across the U.S. and Europe
Stellaromics Expands Pyxa® Adoption as Instruments are Installed at Leading Research Institutions Across the U.S. and Europe Icahn School of Medicine at Mount Sinai, CNAG, Karolinska Institutet, and Stanford University will apply 3D spatial multi-omics across...
Freeze-Dried Does Not Mean Pathogen-Free
Once concentrated in commercial manufacturing, freeze-drying has entered home kitchens and small food businesses through countertop equipment. That shift has made freeze-dried food safety a live question for small operators. University of Minnesota Extension describes...
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...
Twin B7-H3 ADC Wins in Seoul Leave the UK Route Unresolved
Two B7-H3 ADC readouts landed in the same Seoul session on 13 September 2026. Both reported a survival win in relapsed small cell lung cancer. Both trials ran entirely in China. Neither dataset, on its own, is a filing package for the FDA, the EMA or the MHRA. Two...
Collagen Bioinks: A New Standard for 3D-Printed Tissue Constructs
Collagen bioinks have to satisfy two very different demands. They need to behave predictably during printing, and once the printing stops they must also provide an environment in which cells can organise and begin behaving like tissue. However, it’s typically the...
Autoimmune Serology Redefined: Deep B-Cell Depletion and IgG Blockade
In October 2025, the FDA approved an anti-CD20 monoclonal antibody for adults with active lupus nephritis receiving standard therapy. In the phase 3 REGENCY trial, 46.4% of patients receiving B-cell depletion plus standard therapy achieved a complete renal response at...
Radial Immunodiffusion Protocol and Troubleshooting: Why RID Still Matters
Abstract Radial immunodiffusion (RID) can look almost outdated beside ELISA, multiplex assays, and automated analytical platforms. Yet that apparent simplicity may be exactly why the method still deserves attention. RID offers a direct, visually interpretable way to...
Weekly News Roundup | 14 September 2026
Life science news 14 September 2026: two US approvals for rare diseases, a landmark antibody-drug conjugate readout, and two UK moves on pharmacy access and AI oversight. Scholar Rock’s Isembyld won FDA approval, described by the agency as the first SMA therapy to...
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...
Medical AI Is Getting Better. Why Is Diagnosis Getting Harder?
A radiologic study today rarely arrives alone. It comes wrapped in automated detection flags, quantitative lesion scores, an AI-drafted report, historical imaging, EHR clinical notes, and subspecialty consult requests. What it does not come wrapped in is medical AI...
Stellaromics Expands Pyxa Adoption Across the U.S. and Europe
Stellaromics Expands Pyxa® Adoption as Instruments are Installed at Leading Research Institutions Across the U.S. and Europe Icahn School of Medicine at Mount Sinai, CNAG, Karolinska Institutet, and Stanford University will apply 3D spatial multi-omics across...
Freeze-Dried Does Not Mean Pathogen-Free
Once concentrated in commercial manufacturing, freeze-drying has entered home kitchens and small food businesses through countertop equipment. That shift has made freeze-dried food safety a live question for small operators. University of Minnesota Extension describes...
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...
Twin B7-H3 ADC Wins in Seoul Leave the UK Route Unresolved
Two B7-H3 ADC readouts landed in the same Seoul session on 13 September 2026. Both reported a survival win in relapsed small cell lung cancer. Both trials ran entirely in China. Neither dataset, on its own, is a filing package for the FDA, the EMA or the MHRA. Two...
Collagen Bioinks: A New Standard for 3D-Printed Tissue Constructs
Collagen bioinks have to satisfy two very different demands. They need to behave predictably during printing, and once the printing stops they must also provide an environment in which cells can organise and begin behaving like tissue. However, it’s typically the...
Autoimmune Serology Redefined: Deep B-Cell Depletion and IgG Blockade
In October 2025, the FDA approved an anti-CD20 monoclonal antibody for adults with active lupus nephritis receiving standard therapy. In the phase 3 REGENCY trial, 46.4% of patients receiving B-cell depletion plus standard therapy achieved a complete renal response at...
Radial Immunodiffusion Protocol and Troubleshooting: Why RID Still Matters
Abstract Radial immunodiffusion (RID) can look almost outdated beside ELISA, multiplex assays, and automated analytical platforms. Yet that apparent simplicity may be exactly why the method still deserves attention. RID offers a direct, visually interpretable way to...
Weekly News Roundup | 14 September 2026
Life science news 14 September 2026: two US approvals for rare diseases, a landmark antibody-drug conjugate readout, and two UK moves on pharmacy access and AI oversight. Scholar Rock’s Isembyld won FDA approval, described by the agency as the first SMA therapy to...
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...
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Clinical Trials Roundup | 11 Sept 2026
Novo Nordisk’s semaglutide meets its primary endpoint in children aged six to under 12 in the Phase 3 STEP Young obesity trial, Novartis’s del-desiran misses its primary endpoint in the Phase 3 HARBOR study in myotonic dystrophy type 1, Pharvaris’s deucrictibant XR...
Most Favoured Nation Pricing: What 26 Company Agreements Actually Commit To
Most favoured nation pricing is now the central instrument of United States drug pricing policy. On 31 August 2026, the White House announced agreements with nine further manufacturers. That brought the administration’s stated total to 26 companies, covering 89 per...
Partial Clinical Hold Lands on Opakalim Before SK Deal Closes
The US Food and Drug Administration has imposed a partial clinical hold on Biohaven’s epilepsy candidate opakalim. The hold took effect on 4 September 2026. Biohaven disclosed it in a Form 8-K filed on 10 September 2026. The measure stops new enrolment across the...
The Other Half of Innovation
What does the word "innovation" typically evoke in wound care? For many, it brings to mind a new biomaterial, a novel mechanism, or a breakthrough product supported by promising data and clinical validation. These advancements matter. But they raise a more fundamental...
Rakuten Medical Appoints Former Takeda CEO Christophe Weber to Board
Rakuten Medical Appoints Christophe Weber as Vice Chairman and Ken Takeshita, M.D., as Director to Accelerate US Growth and Oncology Innovation Enhanced Board and leadership team, including the appointment of a new Chief Medical Officer, strengthens governance,...
Why Hormone Health Knowledge Could Improve Female Staff Retention
The life sciences sector is built on evidence, innovation and better health outcomes. So why is women’s hormone health at work still so often treated as a peripheral issue, asks Sarah Davies, Managing Director of Balance@Work? Life sciences organisations spend their...
Tozorakimab COPD Trial Data Reach Below the Eosinophil Gate
AstraZeneca released the full tozorakimab COPD trial results on 8 September 2026. The company presented them as a late breaker at the European Respiratory Society Congress in Barcelona. The slot was the ALERT-2 plenary session. The New England Journal of Medicine...
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...
Regenerative Biologics and Biomaterials in Modern Aesthetic Surgery
The Shift Toward Regenerative Surgery When I trained, the reconstructive mindset in plastic surgery was largely mechanical. The goal was to restore form by moving tissue, removing what was damaged, or replacing what was missing, while accepting some degree of scarring...
Coming Off Weight Loss Injections: The Oral Maintenance Option
Orforglipron (Foundayo) is now available in the UK following The Medicines and Healthcare products Regulatory Agency (MHRA) approval on 10 August, making the UK the first European country to license it for weight management and type 2 diabetes. The first oral...
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...
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See More Articles
Want to Be Part of the Next Chapter in Life Sciences Media?
LifeScienceDaily.news is building a new kind of platform where innovators, researchers, and industry leaders tell their own stories and shape the narrative of what’s next in life sciences. Share your story and lead the conversation.