Regulatory Science

Taysha reaffirms FDA BLA pathway for TSHA-102 Rett syndrome gene therapy

Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
Taysha Gene Therapies confirmed FDA alignment on its BLA submission route for TSHA-102, with pivotal trial dosing on track to complete in Q2 2026.
The Biotech Times Editorial Team  · 
Digital Health

Simple Charm positions AI beauty devices as a biotech-grade play

Topband-backed Simple Charm claims professional-grade precision for home beauty devices via AI facial recognition and ultrasonic technology.
Topband-backed Simple Charm claims professional-grade precision for home beauty devices via AI facial recognition and ultrasonic technology.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Idorsia shareholders back all board proposals at 2026 AGM

Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
Idorsia's 2026 AGM approved three new board members and reaffirmed Jean-Paul Clozel as chairman, with a CEO search ongoing.
The Biotech Times Editorial Team  · 
Regulatory Science

Picard Medical prices $5m offering to clear debt and fund operations

The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.
The SynCardia parent raises $5m via shares and warrants at $0.30, using proceeds to repay senior secured notes and support working capital.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health

Philips posts 4% comparable sales growth and margin gain in Q1 2026

Royal Philips reported EUR 3.9bn in Q1 sales, 6% order intake growth and FDA clearances for four AI-powered imaging systems, reiterating its full
Royal Philips reported EUR 3.9bn in Q1 sales, 6% order intake growth and FDA clearances for four AI-powered imaging systems, reiterating its full
The Biotech Times Editorial Team  · 
Diagnostics

Jelly Lean gummy supplement rides viral "Pink Gelatin Trick" wave

A ClickBank-distributed ACV and BHB gummy has surged in searches after a viral pre-meal satiety trend, but counterfeit listings cloud the market.
A ClickBank-distributed ACV and BHB gummy has surged in searches after a viral pre-meal satiety trend, but counterfeit listings cloud the market.
The Biotech Times Editorial Team  · 
Genomics
Biotech

Madrigal licenses Arrowhead's PNPLA3 siRNA for $1bn in MASH push

Madrigal Pharmaceuticals has licensed ARO-PNPLA3 from Arrowhead, targeting a common genetic driver of MASH prevalent in Hispanic patients.
Madrigal Pharmaceuticals has licensed ARO-PNPLA3 from Arrowhead, targeting a common genetic driver of MASH prevalent in Hispanic patients.
The Biotech Times Editorial Team  · 
Medical Devices

LeMaitre Vascular posts 11% Q1 sales growth on Artegraft expansion

The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
The Burlington-based vascular device maker reported Q1 2026 sales of $66.6m, with EPS up 42% year-on-year and full-year guidance raised.
The Biotech Times Editorial Team  · 
Biotech

Kymera Therapeutics unveils KT-579 IBD preclinical data at DDW

Kymera's oral IRF5 degrader matched or outperformed JAK inhibitors and biologics in a preclinical IBD model; Phase 1 human data are due in the
Kymera's oral IRF5 degrader matched or outperformed JAK inhibitors and biologics in a preclinical IBD model; Phase 1 human data are due in the
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
The Biotech Times Editorial Team  · 
Bioprocessing

InterCure posts NIS 270m revenue in 2025 as war recovery accelerates

Israel's Canndoc parent reported 13% revenue growth and a twelfth consecutive half-year of positive Adjusted EBITDA as it rebuilt from the October 2023
Israel's Canndoc parent reported 13% revenue growth and a twelfth consecutive half-year of positive Adjusted EBITDA as it rebuilt from the October 2023
The Biotech Times Editorial Team  · 
Biotech

Integra LifeSciences posts Q1 revenue of $391.9m amid leadership change

The medical technology group beat its adjusted EPS guidance and named Stuart Essig as CEO as its Tissue Reconstruction unit led organic growth.
The medical technology group beat its adjusted EPS guidance and named Stuart Essig as CEO as its Tissue Reconstruction unit led organic growth.
The Biotech Times Editorial Team  · 
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