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WHO Adds First Ebola Bundibugyo Diagnostic Test to Emergency Use Listing Amid DRC Outbreak

WHO Launches PARTNERS Trial Enrolling BVD Patients to Evaluate MBP134 and Remdesivir

Aarti Pharmalabs Inaugurates Tarapur Block, Lifting Xanthine Derivatives Capacity to 9,600 TPA

Rockwell Automation and Cisco Sign Manufacturing Partnership to Advance AI-Driven Operations in India

Latest news
11 storiesRoche Establishes Second India Digital Tech Hub in Hyderabad for Global Operations
Roche's second India digital hub in Hyderabad, due Q1 2027, expands its global technology network supporting manufacturing and quality operations.

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

ID Biomedical Gains FDA Approval for FluLaval Quadrivalent Ahead of 2026–2027 Influenza Season
FDA approves FluLaval Quadrivalent for 2026–2027 season; lot release and GMP compliance timelines now active for ID Biomedical.

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

FDA Investigates Sevoflurane Safety After Neurologic Deaths Linked to Mitochondrial Variant in Venezuelan-Ancestry Patients
FDA is investigating sevoflurane and volatile anesthetics after neurologic deaths linked to a rare mitochondrial variant in Venezuelan-ancestry patients.

FDA Updates Authorized Generics Listing, Flagging Data Gaps NDA Sponsors Must Verify
FDA's July 2026 authorized generics update flags data gaps NDA sponsors must independently verify before relying on market-entry timelines.

Glenmark Advances Phase 3 Trial of HER2-Targeted ADC for Platinum-Resistant Ovarian Cancer
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 Appoints Siddharth Mittal as MD and CEO Following Leadership Transition
Syngene names Siddharth Mittal MD and CEO; his 13-year CFO tenure at Biocon shapes expectations for CDMO capacity and partnership strategy.

NKGen Biotech Presents Troculeucel NK Cell Therapy at BIOCHINA 2026 Forum in Seoul
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.

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

EMA Launches Women's Health Initiative Targeting Clinical Trial Design and Labelling Requirements
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.

Worth your time this week

Corline Biomedical Achieves 60-Month Safety Confirmation for Renaparin in Kidney Transplantation

Anaveon Appoints Laetitia Pouzol as Chief Scientific Officer to Lead ANV200 IND Strategy

Roche Achieves Phase III Superiority for Divarasib Against Approved KRAS G12C Inhibitors in NSCLC
