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Results For "authorization"

338 News Found

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C
News | January 28, 2026

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients


AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder
Biotech | January 20, 2026

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder

Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector


Venus Remedies secures marketing authorisation for Ceftazidime + Avibactam in Indonesia
News | January 16, 2026

Venus Remedies secures marketing authorisation for Ceftazidime + Avibactam in Indonesia

Approval marks Venus Remedies’ first anti-infective marketing authorization in Indonesia and enables the country’s first generic entry for this critical antibiotic combination


Firstsource acquires TeleMedik
Healthcare | January 14, 2026

Firstsource acquires TeleMedik

The acquisition combines Firstsource’s market-leading AI and automation capabilities with TeleMedik’s operational footprint in Puerto Rico


Organon strikes deal with Daiichi Sankyo to launch breakthrough cholesterol drug in Northern Europe
News | January 12, 2026

Organon strikes deal with Daiichi Sankyo to launch breakthrough cholesterol drug in Northern Europe

This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo to patients in France, Denmark, Iceland, Sweden, Finland and Norway


InflaRx shifts focus to lead drug, cuts costs by 30% to extend cash runway
Biopharma | January 11, 2026

InflaRx shifts focus to lead drug, cuts costs by 30% to extend cash runway

InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development


Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy
News | January 08, 2026

Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy

REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


GenSight Biologics gets early access nod for candidate gene therapy in Israel
Clinical Trials | December 31, 2025

GenSight Biologics gets early access nod for candidate gene therapy in Israel

Applications include detailed scientific rationale and supporting clinical evidence


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies