Cingulate publishes Phase 3 data for CTx-1301 ADHD candidate

All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
The Biotech Times Editorial Team  · 
Biologics

Annexon secures $200m credit facility from Oxford Finance

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Biotech Times Editorial Team  · 
Regulatory Science

Abivax clears FDA pre-NDA meeting for obefazimod in ulcerative colitis

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Pfizer-BioNTech win EC nod for XFG-adapted COVID-19 vaccine

The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The Biotech Times Editorial Team  · 
Biologics

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
The Biotech Times Editorial Team  · 
Biologics

Claris Bio raises $118m Series B to fund pivotal LSCD eye-drop study

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The Biotech Times Editorial Team  · 
Biologics

Dyne Therapeutics gains FDA Priority Review for DMD drug z-rostudirsen

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
The Biotech Times Editorial Team  · 
Biologics

Ipsen raises FY 2026 guidance after 23.5% CER sales growth in H1

Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
Ipsen lifted its full-year sales growth target to above 20% at CER after H1 revenues hit €2.19bn, driven by pipeline progress across oncology
The Biotech Times Editorial Team  · 
Diagnostics

MannKind's nintedanib DPI clears Phase 1b safety bar in IPF

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
The Biotech Times Editorial Team  · 
Regulatory Science

Idorsia QUVIVIQ sales jump 62% as daridorexant pipeline broadens

Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand
Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand
The Biotech Times Editorial Team  · 
Regulatory Science

PolyPid secures FDA Priority Review for D-PLEX100 NDA

The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Biotech Times Editorial Team  · 
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