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Regulatory Science

Bavarian Nordic files chikungunya vaccine for approval in Brazil

Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
The Biotech Times Editorial Team  · 
Regulatory Science

Incannex secures US patent for IHL-42X sleep apnoea therapy to 2040

Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
The Biotech Times Editorial Team  · 
Regulatory Science

CervoMed secures US patent on neflamapimod for pure DLB to 2042

CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
The Biotech Times Editorial Team  · 
Regulatory Science

Cingulate secures first US patent on CTx-1301 ADHD tablet

The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The Biotech Times Editorial Team  · 
Regulatory Science

Serenity Medical wins FDA Breakthrough Device tag for tinnitus stent

The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's Nexviazyme hits all endpoints in infantile Pompe phase 3

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics
Regulatory Science

Mdxhealth GPS-ProMPT study published in European Urology Oncology

The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Roche's Enspryng wins FDA Priority Review for thyroid eye disease

The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

AdJane reports first human proof-of-concept for intranasal OMV vaccine

The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
The Dutch biotech's Phase I data show its nOMV platform induced mucosal and systemic immunity in healthy adults, published in peer-reviewed journal Vaccines.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor's DMD cell therapy Deramiocel heads to FDA advisory panel

The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The Biotech Times Editorial Team  · 
Genomics
Regulatory Science

Taysha Gene Therapies presents TSHA-102 Rett data at IRSF 2026

Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.
Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

INmune Bio wins MHRA PIP approval for Ebstrocel in RDEB

The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
The Biotech Times Editorial Team  · 
Regulatory Science

EMBARC and Insmed to run 3,000-patient brensocatib study

The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.
The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.
The Biotech Times Editorial Team  · 
Regulatory Science

Chiesi and Arbor win EU orphan designation for ABO-101 in PH1

The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.
The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.
The Biotech Times Editorial Team  · 
Regulatory Science

Elevar Therapeutics doses first patients in FGFR2 Phase 2 expansion

Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.
Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.
The Biotech Times Editorial Team  · 
Regulatory Science

Agomab aligns with FDA on Phase 2b NOV-ERA design for FSCD

Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
The Biotech Times Editorial Team  · 
Regulatory Science

BridgeBio to present Phase 3 infigratinib achondroplasia data at ICCBH

BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
The Biotech Times Editorial Team  · 
Regulatory Science

Nephros touts ultrafiltration tech as microplastic risk gains EPA focus

Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
Nephros says its 5-nanometre pore filters capture both microplastics and nanoplastics, following the EPA's April 2026 decision to prioritise plastic particle
The Biotech Times Editorial Team  · 
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