Biologics
Pharmaceuticals

Medicenna to present bizaxofusp rGBM survival data at SNO 2026

Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Vistagen sees fasedienol signal in severe social anxiety

Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Newron's ENIGMA-TRS 2 US enrolment hold stays as ex-US sites expand

The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
The Biotech Times Editorial Team  · 
Digital Health

Chrysalis Health and Curaechoice partner on no-cost mental health access

The tie-up gives self-funded employer health plan members access to Chrysalis Health's 80-plus outpatient sites and virtual services at no out
The tie-up gives self-funded employer health plan members access to Chrysalis Health's 80-plus outpatient sites and virtual services at no out
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Addex regains global GABAB PAM rights after Indivior R&D pullback

Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
Addex Therapeutics has reclaimed its full GABAB positive allosteric modulator portfolio from Indivior, citing the UK firm's R&D rationalisation ahead of a planned
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Pharmaceuticals

CARVYKTI gives five-year remissions to 50% in early-line myeloma

Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
Five-year CARTITUDE-2 data show half of early-line RRMM patients remained alive and progression-free after a single cilta-cel infusion, with no
The Biotech Times Editorial Team  · 
Diagnostics
Biologics
Cell & Gene Therapy

Adaptive Biotechnologies cites clonoSEQ in new myeloma cure definition

A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

ADARx Pharmaceuticals prices $446m IPO on Nasdaq

The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Avacta presents FOCUS-01 trial design and AVA6103 PDAC data at AACR

Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

EC approves leriglitazone as first pharmacological cALD treatment

Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
Neuraxpharm and Minoryx win EU marketing authorisation for NEZGLYAL, the first oral drug approved for cerebral adrenoleukodystrophy in young boys.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health
Diagnostics

Firefly and NeuroSigma partner to distribute FDA-cleared ADHD device

Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.
Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.
The Biotech Times Editorial Team  · 
Proteomics
Diagnostics
Biologics

Alamar Biosciences platform underpins Lancet Neurology lecanemab study

A Washington University cohort study used Alamar's 130-protein plasma panel to show amyloid clearance and cognitive response reflect distinct biological processes.
A Washington University cohort study used Alamar's 130-protein plasma panel to show amyloid clearance and cognitive response reflect distinct biological processes.
The Biotech Times Editorial Team  · 
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