IMFINZI Receives Priority Review in US for Muscle-Invasive Bladder Cancer
AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) and granted it Priority Review. The application seeks approval…
Senegal and Rwanda Attain WHO Maturity Level 3 for Medicines Regulation
Senegal and Rwanda have joined an elite group of African nations by achieving Maturity Level 3 (ML3) status in the World Health Organization’s (WHO) global classification of national regulatory authorities.…
Webinar Leveraging Digital and Analytics Tools in Mpox Response
Between January 2022 and October 2024, over 120 countries reported cases of mpox, marking a significant multi-country outbreak that impacted all WHO regions. In response, public health professionals convened in…
LEQEMBI (Lecanemab) Gains Approval in Mexico for Early Alzheimer’s Treatment
Eisai and Biogen Inc. have announced that Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) has approved LEQEMBI (lecanemab), a humanized monoclonal antibody, for the treatment of early…
EU Approves Novo Holdings’ Catalent Acquisition and Novo Nordisk’s Site Purchase
Today, the European Commission officially approved the acquisition of Catalent, Inc. by Novo Holdings A/S, a deal that will further expand the capabilities of the Novo Group. Catalent, a global…
CVS Health Corporation Announces Pricing for Comprehensive Tender Offer
CVS Health Corporation has disclosed the Reference Yield and Total Consideration for its previously announced cash tender offer (the “Any and All Tender Offer”) targeting its 4.100% Senior Notes due…
AstraZeneca Appoints Iskra Reic as EVP, International
AstraZeneca announced the appointment of Iskra Reic as Executive Vice President (EVP), International, effective immediately. Reic will oversee the company’s strategy and growth across the vast International region, including markets…
WHO Prequalifies First Single-Dose Medicine for P. vivax Malaria and Includes it in Guidelines
GSK plc and Medicines for Malaria Venture (MMV) have announced a major milestone in the fight against malaria, as the World Health Organization (WHO) has awarded prequalification to tafenoquine. This…
Lilly Clinches Major Weight Loss Win Over Novo in Head-to-Head Study
Eli Lilly has unveiled promising data from its Phase IIIb SURMOUNT-5 study, showing that its weight loss treatment, Zepbound (tirzepatide), outperforms Novo Nordisk’s Wegovy (semaglutide) in terms of weight reduction.…
FDA Issues Warning to Applied Therapeutics Over Objectionable Conditions’ in Govorestat Study
Applied Therapeutics, the biopharmaceutical company focused on developing treatments for rare diseases, recently received a warning letter from the U.S. Food and Drug Administration (FDA) following concerns raised about the…
BeiGene and CLL Society Partner to Promote Biomarker Testing in CLL
BeiGene a global leader in oncology, has announced a new partnership with the CLL Society, the premier authority for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) cancer patients.…
Tips for Staying Healthy During the Holidays
If public transportation is your ticket to holiday cheer, it’s vital to take precautions to avoid illness while en route. Hand hygiene is your first line of defense during the…