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

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

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

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

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

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

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

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent

AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo

Mycenax and Spera forge alliance to streamline ADC drug substance