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Industry leaders call for a new era of collaboration, innovation, and self-reliance
News | November 03, 2025

Industry leaders call for a new era of collaboration, innovation, and self-reliance

Building a transparent, data-driven supply chain and self-reliant API ecosystem remains critical to reducing import dependence


EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours
Clinical Trials | October 31, 2025

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1


BMS unveils new data highlighting sustained efficacy and safety of Sotyktu in psoriatic arthritis and lupus
Clinical Trials | October 30, 2025

BMS unveils new data highlighting sustained efficacy and safety of Sotyktu in psoriatic arthritis and lupus

Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions


FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer
Drug Approval | October 23, 2025

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial


FDA approves Tezspire for chronic rhinosinusitis with nasal polyps
Drug Approval | October 21, 2025

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation


AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain
News | October 06, 2025

AGC Pharma Chemicals opens new €100 million manufacturing plant in Spain

It represents a 30% increase in the company’s production capacity and introduces a segment dedicated to highly potent active ingredients


Fujifilm Biotechnologies opens cell culture manufacturing site in North Carolina
Biotech | September 26, 2025

Fujifilm Biotechnologies opens cell culture manufacturing site in North Carolina

Represents one of the largest cell culture biomanufacturing sites in North America, which will employ 1,400 people by 2031


AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1
Drug Approval | September 24, 2025

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population


Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment
News | September 24, 2025

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion


Moderna delivers Canada’s first locally manufactured mRNA vaccines
News | September 23, 2025

Moderna delivers Canada’s first locally manufactured mRNA vaccines

All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec