Regulatory Science

FDA grants ZYN nicotine pouches modified risk tobacco status

Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing
Philip Morris International's ZYN pouches become the first nicotine pouches to receive FDA Modified Risk Tobacco Product authorisation, allowing lower-risk marketing
The Biotech Times Editorial Team  · 
Biologics

argenx acquires Forte Biosciences, adding anti-CD122 antibody

argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Pfizer and BioNTech win FDA approval for XFG-adapted COMIRNATY

The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.
The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.
The Biotech Times Editorial Team  · 
Diagnostics

Verrica completes COVE-2 enrolment for YCANTH common warts label

Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50
Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50
The Biotech Times Editorial Team  · 
Digital Health

BrainsWay Deep TMS data show 70% cut in suicidal ideation in MDD

A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
A peer-reviewed secondary analysis found suicidal ideation fell from 22.5% to 6.7% of patients after six weeks of Deep TMS treatment for
The Biotech Times Editorial Team  · 
Biologics

Corvus Pharmaceuticals publishes Phase 1 soquelitinib data in Blood

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
The Biotech Times Editorial Team  · 
Biologics

MBX Biosciences doses first patient in Phase 3 canvuparatide trial

The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.
The NASDAQ-listed biotech has initiated its pivotal oPTimize study of once-weekly canvuparatide in roughly 160 adults with chronic hypoparathyroidism.
The Biotech Times Editorial Team  · 
Diagnostics

Conavi Medical wins FDA 510(k) for hybrid IVUS-OCT imaging system

The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
The Biotech Times Editorial Team  · 
Biologics

CytomX wins FDA Fast Track for EpCAM ADC in metastatic colorectal cancer

The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
The FDA granted Fast Track Designation to Varseta-M, an EpCAM-directed ADC, ahead of a planned registrational study starting in early 2027.
The Biotech Times Editorial Team  · 
Biologics

Priovant wins FDA approval for brepocitinib in dermatomyositis

LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Roivant's brepocitinib wins FDA approval for dermatomyositis

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
The Biotech Times Editorial Team  · 
Regulatory Science

Nicox NCX 470 glaucoma NDA accepted with April 2027 PDUFA date

The FDA has set a 30 April 2027 review deadline for NCX 470, a nitric oxide-donating bimatoprost eye drop targeting open-angle glaucoma.
The FDA has set a 30 April 2027 review deadline for NCX 470, a nitric oxide-donating bimatoprost eye drop targeting open-angle glaucoma.
The Biotech Times Editorial Team  · 
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