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Multiply Labs is revolutionizing cell therapy production with ai

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins.

Multiply Labs is revolutionizing cell therapy production with robotic systems and AI-driven digital twins, cutting costs by up to 70%, increasing throughput, and reducing contamination ri

The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals

Royal Osteoporosis Society urges Britons to check bone health risk

New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
New polling shows 80% of UK adults have never assessed their bone health, despite osteoporosis causing 550,000 fractures annually.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

First Tracks' ANB033 hits goals in coeliac gluten challenge

ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Acoramidis beats tafamidis on cardiac outcomes in real-world EHR study

A propensity-matched analysis of nearly 2,700 ATTR-CM patients found acoramidis cut composite cardiovascular risk by 18% versus tafamidis.
A propensity-matched analysis of nearly 2,700 ATTR-CM patients found acoramidis cut composite cardiovascular risk by 18% versus tafamidis.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Idorsia aprocitentan shows double-digit BP cuts in obesity and CKM

Post hoc PRECISION analyses presented at AHA 2026 show aprocitentan cut systolic BP by over 15 mmHg and reduced UACR by nearly 50% in high
Post hoc PRECISION analyses presented at AHA 2026 show aprocitentan cut systolic BP by over 15 mmHg and reduced UACR by nearly 50% in high
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

XORTX plans Health Canada CTA filing for gout candidate XRx-026

The Calgary biotech aims to file a Clinical Trial Application in Canada to accelerate data generation for its planned FDA NDA submission for XORLO.
The Calgary biotech aims to file a Clinical Trial Application in Canada to accelerate data generation for its planned FDA NDA submission for XORLO.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

InnoCare wins China IND approval for TL1A/IL-23p19 bispecific ICP-B161

InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

BridgeBio encaleret hits ADH1 endpoints as NDA earns Priority Review

Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Milestone Pharma enrols first European patient in AFib-RVR trial

Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.
Milestone Pharmaceuticals has expanded its ReVeRA-301 Phase 3 trial to Europe, enrolling the first patient through the Dutch WCN cardiovascular network.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Roche vamikibart hits 52-week UME endpoints as FDA weighs BLA

Phase III MEERKAT and SANDCAT data show sustained vision gains at one year, with an FDA approval decision expected by July 2027.
Phase III MEERKAT and SANDCAT data show sustained vision gains at one year, with an FDA approval decision expected by July 2027.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Pharmaceuticals

Profound Medical and Telix link up on PSMA-PET and MRI prostate care

The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The two commercial-stage companies will co-educate physicians on combining PSMA-PET imaging with Profound's MRI-guided TULSA-PRO ablation platform.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

NovaBridge to present givastomig Phase 1b data at ESMO 2026

Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
Updated safety and efficacy data for the CLDN18.2x4-1BB bispecific will be presented at ESMO Congress in Madrid on 25 October.
The Biotech Times Editorial Team  · 
Medical Devices
Pharmaceuticals

Beyond Air posts record $2.3m quarter as LungFit PH adoption grows

Beyond Air said Q3 2026 revenue rose 30% sequentially to $2.3m, its highest ever, while its second-generation nitric oxide system awaits FDA approval.
Beyond Air said Q3 2026 revenue rose 30% sequentially to $2.3m, its highest ever, while its second-generation nitric oxide system awaits FDA approval.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Daré Bioscience presents sildenafil cream Phase 1 data at SMSNA 2026

Phase 1 data showed topical sildenafil delivered 187-fold lower peak plasma concentrations than oral dosing, supporting FSAD programme advancement.
Phase 1 data showed topical sildenafil delivered 187-fold lower peak plasma concentrations than oral dosing, supporting FSAD programme advancement.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biotech

Tilray Brands posts record Q1 revenue of $257m, up 23% year-on-year

Tilray Brands reported record first-quarter net revenue of $257m, driven by beverage growth and EMEA expansion, while reaffirming its fiscal 2027 adjusted EBITDA
Tilray Brands reported record first-quarter net revenue of $257m, driven by beverage growth and EMEA expansion, while reaffirming its fiscal 2027 adjusted EBITDA
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Idorsia daridorexant Phase 2 paediatric data to headline Sleep Europe

Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
Idorsia will present the first clinical data for a dual orexin receptor antagonist in children with insomnia at Sleep Europe 2026 in Maastricht.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Sagimet's denifanstat shows sustained acne efficacy at 52 weeks

Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
Phase 3 extension data from Ascletis' China trial show 57% IGA success and 77% inflammatory lesion reduction; Sagimet's US AURORA trial is now screening
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Teva wins FDA approval for WELTRUZA once-monthly olanzapine

Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
Teva's subcutaneous olanzapine LAI requires no loading doses, no oral supplementation and no post-injection monitoring, the FDA ruled.
The Biotech Times Editorial Team  · 
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