Regulation

Regulatory Science

Crossject closes €15m equity raise to advance ZEPIZURE EUA process

The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.
The Dijon-based emergency-medicines specialist issued new shares and warrants to fund regulatory steps for its needle-free seizure treatment and ramp production capacity.
The Biotech Times Editorial Team  · 
Regulatory Science

Signati Medical wins FDA IDE approval for Separo vasectomy device trial

The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.
The Providence-based medtech has cleared FDA's IDE process, unlocking a 120-subject pivotal RCT comparing Separo to standard mucosal cautery vasectomy.
The Biotech Times Editorial Team  · 
Regulatory Science

Chiesi wins EC approval for lomitapide in children with HoFH

The European Commission has expanded lomitapide's indication to children aged five and older with homozygous familial hypercholesterolaemia, backed by Phase 3 data.
The European Commission has expanded lomitapide's indication to children aged five and older with homozygous familial hypercholesterolaemia, backed by Phase 3 data.
The Biotech Times Editorial Team  · 
Diagnostics

Cloudbreak Pharma completes final visits for Phase 3 pterygium trial

Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.
Topline 12-month efficacy data for CBT-001, a potential first FDA-approved pterygium drug, are expected in Q3 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

BioCardia wins FDA backing for single-trial PMA path for CardiAMP

FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
The Biotech Times Editorial Team  · 
Regulatory Science

Memo Therapeutics presents Phase II data on potravitug for BKPyV

Propensity-score-matched analysis showed potravitug nearly doubled viral clearance rates vs controls in kidney transplant recipients with BK polyomavirus infection.
Propensity-score-matched analysis showed potravitug nearly doubled viral clearance rates vs controls in kidney transplant recipients with BK polyomavirus infection.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy

Alpha Tau and Tolmar partner to commercialise Alpha DaRT in U.S.

Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
Alpha Tau secures a $35M upfront package from Tolmar, plus up to $161.5M in milestones, for exclusive U.S. prostate cancer rights to its
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis ALIGN data show Vanrafia slows IgAN kidney decline by 34%

Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.
Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.
The Biotech Times Editorial Team  · 
Diagnostics

Spectral Medical PMX shows sustained mortality benefit at 12 months

Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
The Biotech Times Editorial Team  · 
Regulatory Science

Iovance wins TGA approval for lifileucel in advanced melanoma

Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.
Amtagvi becomes the first T cell therapy approved for a solid tumour in Australia, the country with the world's highest melanoma incidence.
The Biotech Times Editorial Team  · 
Regulatory Science

Artios Pharma adds three executives as alnodesertib nears registration

The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.
The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.
The Biotech Times Editorial Team  · 
Regulatory Science

Cristcot names Rayna Herman to lead HCA commercial division

Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
The Biotech Times Editorial Team  · 
Regulatory Science

Immunocore posts $107m KIMMTRAK quarter with landmark five-year OS data

KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

Philips posts 4% comparable sales growth and margin gain in Q1 2026

Royal Philips reported EUR 3.9bn in Q1 sales, 6% order intake growth and FDA clearances for four AI-powered imaging systems, reiterating its full
Royal Philips reported EUR 3.9bn in Q1 sales, 6% order intake growth and FDA clearances for four AI-powered imaging systems, reiterating its full
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Idorsia shareholders back all board proposals at 2026 AGM

Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
The Biotech Times Editorial Team  · 
Regulatory Science

Taysha reaffirms FDA BLA pathway for TSHA-102 Rett syndrome gene therapy

Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

Trethera to present TRE-515 optic neuritis data at LABEST 2026

The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The Biotech Times Editorial Team  · 
Subscribe to Regulation