NewsWHO lists first molecular diagnostic for Ebola Bundibugyo virus under EUL, seven weeks after PHEIC declaration over the DRC outbreak.




FDA grants Sanofi concurrent annual approval for Fluzone and Fluzone High-Dose, confirming 2026–27 seasonal authorization under STN BL 103914.

FDA approves FluLaval Quadrivalent for 2026–2027 season; lot release and GMP compliance timelines now active for ID Biomedical.

FDA approves Seqirus Flucelvax for 2026–2027 season on July 1, continuing annual cell-based influenza vaccine approval cycle.

FDA is investigating sevoflurane and volatile anesthetics after neurologic deaths linked to a rare mitochondrial variant in Venezuelan-ancestry patients.

FDA's July 2026 authorized generics update flags data gaps NDA sponsors must independently verify before relying on market-entry timelines.

Glenmark moves a HER2-targeted ADC into Phase 3 for platinum-resistant ovarian cancer, raising GMP and process validation considerations for ADC manufacturing at scale.

Syngene names Siddharth Mittal MD and CEO; his 13-year CFO tenure at Biocon shapes expectations for CDMO capacity and partnership strategy.

NKGen Biotech's CEO will present troculeucel's Phase 2 data and China free-trade zone regulatory pathways at BIOCHINA 2026 in Seoul on July 10.

FDA CBER issued a March 2026 approval letter for GlaxoSmithKline's Fluarix, shifting the seasonal strain update timeline earlier than prior years.

EMA formalises a women's health initiative across four workstreams, with clinical trial design and labelling obligations set for review ahead of a September workshop.

Corline Biomedical's 60-month STARS-nob data confirm Renaparin® safety and signal eGFR benefit, supporting progression to the 80-patient RENAPAIR 02 trial.




