Regulation

Regulatory Science

Artios Pharma adds three executives as alnodesertib nears registration

The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.
The Cambridge DDR biotech has appointed a Chief Business Officer, General Counsel, and VP of Regulatory Affairs ahead of a potential US commercialisation push.
The Biotech Times Editorial Team  · 
Regulatory Science

Cristcot names Rayna Herman to lead HCA commercial division

Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
Austin-based Cristcot has hired a former Shorla Oncology CCO to head commercial preparations for its FDA-pending ngHCA suppository.
The Biotech Times Editorial Team  · 
Regulatory Science

Immunocore posts $107m KIMMTRAK quarter with landmark five-year OS data

KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
KIMMTRAK net sales grew 14% year-on-year in Q1 2026 as five-year trial data showed the drug doubled survival rates in metastatic uveal
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  · 
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

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  · 
Regulatory Science

Trethera to present TRE-515 optic neuritis data at LABEST 2026

The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The UCLA-founded biotech will show preclinical data on its dCK inhibitor TRE-515 in optic neuritis at a Los Angeles summit on 21 May.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Quoin Pharma maps multi-indication clinical push for QRX009 rapamycin

Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
Quoin Pharmaceuticals is launching investigator-led trials in three rare skin diseases and targeting a first IND filing for QRX009 in Q3 2026.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Orchard Therapeutics wins Innovation Passport for OTL-201 in MPS-IIIA

OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
OTL-201, an HSC gene therapy for the fatal childhood disorder Sanfilippo syndrome type A, is one of the first three therapies designated under the
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices

PRF Technologies wins FDA IND clearance for OcuRing-K cataract trial

PRF Technologies says FDA has cleared its IND for OcuRing-K, enabling a Phase II trial in cataract surgery patients expected to begin enrolling in
PRF Technologies says FDA has cleared its IND for OcuRing-K, enabling a Phase II trial in cataract surgery patients expected to begin enrolling in
The Biotech Times Editorial Team  · 
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