Pharmaceuticals
Regulatory Science

Elevar Therapeutics files EMA application for lirafugratinib in CCA

Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line
Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

BioVie's bezisterim hits subgroup endpoints in Phase 2 Long COVID trial

BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
BioVie reported statistically significant improvements in Long COVID patients with high symptom burden, with Phase 3 now planned for bezisterim.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Kestrel Therapeutics wins FDA Fast Track for pan-KRAS inhibitor KST-6051

Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.
Kestrel's oral pan-KRAS inhibitor enters Phase 1 with Fast Track status, targeting KRAS-mutant solid tumours across PDAC, CRC and NSCLC.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Connect Biopharma's rademikibart cuts asthma treatment failure by 66%

Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

BlossomHill's BH-30643 hits 45% response rate in C797S NSCLC

Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.
Updated SOLARA Phase 1/2 data show an 88% disease control rate in a resistance population with no approved targeted therapies.
The Biotech Times Editorial Team  · 
Genomics
Diagnostics

Bionano OGM detects hidden genomic risk in MDS and AML studies

Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Dogwood Therapeutics completes enrolment in Halneuron CINP Phase 2b

The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
The Atlanta-based biotech enrolled 239 patients at the top of its target range, with topline data expected in November 2026.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

One04 Therapeutics launches on Phase 1 data for Factor H candidate

The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
The Freiburg biotech launched publicly on encouraging CPV-104 Phase 1 interim results in C3G, with two new trials targeting kidney disease and dry AMD
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics
Cell & Gene Therapy

KORTUC hits 184-patient enrolment in registrational breast cancer trial

The Palo Alto radiosensitizer biotech said its UK-led breast cancer study is now moving toward a 2027 efficacy readout, as two further cancer trials
The Palo Alto radiosensitizer biotech said its UK-led breast cancer study is now moving toward a 2027 efficacy readout, as two further cancer trials
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Vera Therapeutics' TRUTAKNA cuts IgAN progression risk 76% in Phase 3

Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4
Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

PolarityBio wins FDA Priority Review for SkinTE BLA in DFUs

The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.
The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.
The Biotech Times Editorial Team  · 
Medical Devices
Diagnostics
Digital Health

Magrabi Health spotlights Centres of Excellence at Forbes Riyadh summit

The Saudi specialist healthcare group used the Forbes Middle East Healthcare Summit 2026 to set out its expansion plans and tout a first-in-world
The Saudi specialist healthcare group used the Forbes Middle East Healthcare Summit 2026 to set out its expansion plans and tout a first-in-world
The Biotech Times Editorial Team  · 
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