Biologics

Manufactured-protein therapeutics: monoclonal antibodies (mAbs); bispecifics & fusion proteins; therapeutic proteins & enzymes; vaccines; and blood & plasma products. Distinct from Cell & Gene Therapy (living cells / genetic material) and from chemically-synthesised small molecules (which stay under Pharmaceuticals).

Pharmaceuticals
Biologics

1ST Bio and SK Biopharma ink $314.8m Parkinson's licence for 1ST-104

The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The deal pairs 1STBIO's dual LRRK2/c-Abl inhibitor with SK Biopharmaceuticals' CNS development and commercialisation infrastructure.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy
Diagnostics
Genomics

NCCN guidelines name clonoSEQ for myeloma MRD testing

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Capricor to present 24-month Deramiocel DMD data at WMS 2026

Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
Capricor Therapeutics will show HOPE-3 skeletal and cardiac outcomes data at the World Muscle Society Congress ahead of its November BLA action date.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Lisata Therapeutics acquires Marea and raises $225m in concurrent PIPE

Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
Lisata is pivoting to cardioendocrine disease after acquiring Marea Therapeutics in a stock deal backed by a $225m oversubscribed private placement.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Novo Nordisk wins CHMP nod for denecimig in haemophilia A

The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
The EMA advisory committee recommended EU approval of FREHEMGO, a bispecific antibody offering monthly, fortnightly or weekly dosing in a pre-filled pen.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Biogen publishes Phase 3 EMPAVELI paediatric data in CJASN

Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
Adolescents with C3G or IC-MPGN achieved a 75% relative reduction in proteinuria on pegcetacoplan versus placebo in the VALIANT subgroup analysis.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy

SNIPR enrolls first Phase 2 patient in CRISPR phage trial

SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
SNIPR has dosed its first Phase 2 patient with SNIPR001, expanding the E. coli bloodstream infection trial to 66 patients across ten sites including MSK
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals
Regulatory Science
Biologics

Ultragenyx wins FDA approval for FAYUVI in Sanfilippo syndrome Type A

FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
FAYUVI becomes the first approved treatment for MPS IIIA, backed by eight years of follow-up data showing significant cognitive benefit over natural history.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Ascendis Pharma to regain TransCon rights in metabolic diseases

Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
Ascendis Pharma will reclaim full rights to its TransCon platform in cardiometabolic indications after ending its Novo Nordisk collaboration.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Avacta reports clinical proof of mechanism for AVA6103 PDC in FOCUS-01

Avacta's next-generation pre|CISION peptide-drug conjugate showed a clean safety profile and matched preclinical PK predictions across three dose levels in solid
Avacta's next-generation pre|CISION peptide-drug conjugate showed a clean safety profile and matched preclinical PK predictions across three dose levels in solid
The Biotech Times Editorial Team  · 
Medical Devices
Biologics
Pharmaceuticals

EIB and Angelini Ventures hit €48.5m deployed under €150m facility

The EIB-Angelini Ventures co-investment partnership has backed five European life sciences companies in under a year, with €100m expected deployed by early 2027.
The EIB-Angelini Ventures co-investment partnership has backed five European life sciences companies in under a year, with €100m expected deployed by early 2027.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Roche's Lunsumio plus lenalidomide meets Phase III PFS endpoint in FL

Roche's CELESTIMO study showed mosunetuzumab plus lenalidomide significantly improved progression-free survival in relapsed or refractory follicular lymphoma.
Roche's CELESTIMO study showed mosunetuzumab plus lenalidomide significantly improved progression-free survival in relapsed or refractory follicular lymphoma.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Tempest Therapeutics options Senlang lentiviral in vivo CAR-T platform

Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR
Tempest secures an exclusive option on Senlang's CD7-targeted lentiviral vector platform, adding a Phase 1 multiple myeloma programme to its in vivo CAR
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
Biologics

ENA Respiratory begins Part B dosing in INNA-051 Phase IIa study

The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
The Melbourne biotech has started dosing up to 900 participants in Part B of its community study of the virus-agnostic nasal spray INNA-051.
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  · 
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  · 
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  · 
Pharmaceuticals
Biologics

Curium wins FDA approval for BEXLUTRY lutetium RLT in GEP-NETs

Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.
Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.
The Biotech Times Editorial Team  · 
Diagnostics
Pharmaceuticals
Biologics

Telix's Pixclara wins FDA approval as first glioma FET-PET agent

Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.
Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.
The Biotech Times Editorial Team  · 
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