Biologics
Pharmaceuticals
Regulatory Science

aTyr Pharma secures FDA alignment on efzofitimod Phase 3 design

aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

MediciNova completes double-blind phase of COMBAT-ALS ibudilast trial

MediciNova has finished the double-blind portion of its 234-patient Phase 2b/3 ALS trial and expects topline results by end of 2026.
MediciNova has finished the double-blind portion of its 234-patient Phase 2b/3 ALS trial and expects topline results by end of 2026.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Pharmaceuticals

Ligand commits up to $47m to back AvenCell's allogeneic CAR-T pipeline

Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Satellos wins FDA IND clearance for forazapadin in FSHD

Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.
Satellos Bioscience has cleared an IND for its AAK1 inhibitor in a second muscle disease, backed by US$5m from the FSHD Canada Foundation.
The Biotech Times Editorial Team  · 
Medical Devices
Digital Health

Precision Neuroscience closes $250m Series D for BCI expansion

The New York BCI company raised an oversubscribed round co-led by Pershing Square, bringing total funding to $430m since its 2021 founding.
The New York BCI company raised an oversubscribed round co-led by Pershing Square, bringing total funding to $430m since its 2021 founding.
The Biotech Times Editorial Team  · 
Diagnostics
Medical Devices
Digital Health

Adaptyx wins FDA Breakthrough Device tag for cortisol monitor

Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal
Adaptyx Biosciences has secured FDA Breakthrough Device Designation and TAP entry for its continuous cortisol wearable, targeting Cushing syndrome and adrenal
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

Actinogen XanaMIA Alzheimer's trial completes visits; data due November

Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.
Actinogen Medical's phase 2b/3 XanaMIA trial has completed all 247 patient visits, with topline results for its oral cortisol inhibitor expected in November.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Bioprocessing

Roquette posts 9% revenue growth in H1 2026 on pharma excipient gains

The French plant-based ingredients group lifted H1 turnover to €2.6bn, with pharmaceutical excipients and its Shift & Lead transformation plan driving margin improvement.
The French plant-based ingredients group lifted H1 turnover to €2.6bn, with pharmaceutical excipients and its Shift & Lead transformation plan driving margin improvement.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices
Regulatory Science

Crossject and BARDA align ZEPIZURE paediatric plan with FDA

An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
An additional $4.7m in non-dilutive BARDA funding extends Crossject's ZEPIZURE development contract through June 2030, bringing total support to $48m.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

HUTCHMED takes savolitinib-osimertinib combo to ESMO 2026

Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
Two positive Phase III NSCLC studies, SAFFRON and SANOVO, will feature as oral presentations at ESMO Congress 2026 in Madrid this October.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

PhAST Corp. wins FDA clearance for rapid blood culture AST panel

PhAST Corp.'s Gram-negative panel delivers antimicrobial susceptibility results in under 2.5 hours directly from positive blood cultures, cutting a typical 24-48
PhAST Corp.'s Gram-negative panel delivers antimicrobial susceptibility results in under 2.5 hours directly from positive blood cultures, cutting a typical 24-48
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

SOTIO wins dual FDA designations for ADC SOT106 in sarcoma

SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
SOTIO Biotech has secured Fast Track and Orphan Drug designations from the FDA for SOT106, its LRRC15-targeting ADC, ahead of a planned first-in
The Biotech Times Editorial Team  · 
Subscribe to