Biotechnology
Novo Says FDA Extends Denecimig BLA Review Over Facility Remediation
Novo Nordisk said in a company announcement on 2 October 2026 that the US Food and Drug Administration has extended its review of the Biologics License Application (BLA) for denecimig for the treatment of haemophilia A, with the agency citing…
$2.2 Billion Ohio Drug Manufacturing Campus Announced by Bayer
Bayer announced on October 2, 2026 that it plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio, describing the project as a central element of its long-term growth strategy and its commitment…
Novonesis Closes MicroBioGen Acquisition After Regulatory Approvals
Novonesis announced on October 1, 2026, that it has completed its acquisition of MicroBioGen, an Australian biotechnology company focused on yeast strains for industrial applications. The Copenhagen-based company stated in its completion announcement that all regulatory approvals have been obtained…
FDA Grants Priority Review to Bayer Lynkuet for Second Indication
The U.S. Food and Drug Administration has accepted Bayer’s supplemental new drug application (sNDA) and granted Priority Review designation for Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, in women receiving…
Imfinzi-Enfortumab Vedotin Wins FDA Priority Review in Bladder Cancer
AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in combination with enfortumab vedotin has been accepted and granted Priority Review by the US Food and Drug Administration for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or…
AstraZeneca’s Trixeo Gains EU Approval as Asthma Maintenance Therapy
AstraZeneca announced on 23 September 2026 that the European Commission has approved Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate, BGF 320/28.8/10μg) as a maintenance treatment for asthma in patients 12 years of age and older who are not adequately controlled by a…
Tempus and Recursion Extend Data Partnership Through November 2029
Tempus AI, Inc. announced on September 21, 2026 that it has extended its data license agreement with Recursion Pharmaceuticals, Inc. through November 2029, and that the two companies have entered into a separate agreement under which Tempus will license Recursion’s…
Novo’s CagriSema Tops Tirzepatide on Weight Loss in Phase 3 Trial
Novo Nordisk on 21 September 2026 reported topline phase 3 results showing that once-weekly CagriSema, its investigational fixed-dose combination of cagrilintide and semaglutide, delivered superior weight loss versus tirzepatide 5 mg in adults with type 2 diabetes and a 21.0%…
CHMP Recommends AstraZeneca’s Klygefa for Generalised Myasthenia Gravis
AstraZeneca announced on 18 September 2026 that Klygefa (gefurulimab), developed by its rare disease unit Alexion, has been recommended for approval in the European Union as an add-on to standard therapy for adults with generalised myasthenia gravis (gMG) who are…
CHMP Backs Adjuvant Enhertu in HER2-Positive Early Breast Cancer
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and…
AstraZeneca Efzimfotase Alfa BLA Granted FDA Priority Review in HPP
AstraZeneca said on 18 September 2026 that the US Food and Drug Administration had accepted the Biologics License Application (BLA) filed by Alexion, AstraZeneca Rare Disease, for efzimfotase alfa and granted the application Priority Review for the treatment of patients…
Adaptive Highlights NCCN Myeloma Guideline Updates Naming clonoSEQ
Adaptive Biotechnologies Corporation announced on September 17, 2026, that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Multiple Myeloma, adding for the first time a dedicated page outlining principles of minimal residual disease…
Bayer Kerendia Wins FDA Approval for Kidney Disease in Type 1 Diabetes
Bayer said on September 17, 2026, that the U.S. Food and Drug Administration has approved Kerendia (finerenone), a selective non-steroidal mineralocorticoid receptor antagonist, for the treatment of adult patients with chronic kidney disease associated with type 1 diabetes. Under the…
Twist Bioscience to Provide Antibody Data Services for Lilly TuneLab
Twist Bioscience Corporation announced on September 16, 2026 an agreement with Lilly TuneLab, a collaborative artificial intelligence and machine learning drug discovery platform created by Eli Lilly and Company . Under the agreement, the South San Francisco-based company is a…
Novo Nordisk Buys Ginkgo Autonomous Lab for New Waltham R&D Site
Ginkgo Bioworks announced on September 15, 2026 that it has been selected to build an autonomous lab powered by its Reconfigurable Automation Cart (RAC) architecture at Novo Nordisk’s new U.S. research and development site in Waltham, Massachusetts. Novo Nordisk purchased…
