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Astrazeneca & Daiichi Sankyo
NEWS

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications

Shots: FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo For neoadj. setting, approval was backed by DESTINY-Breast11…
May 18, 2026

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NEWS

Glooko Secures FDA Clearance for Cloud-Based EndoTool IV Insulin Dosing Platform

Shots: The US FDA has granted 510(k) clearance for EndoTool IV Cloud, a cloud-based patient-specific insulin dosing platform designed for hospitalized pts requiring IV insulin therapy Built on the same dosing algorithm as EndoTool IV, the cloud-based platform is designed to support individualized insulin dosing while enabling more scalable implementation, streamlined maintenance, & reduced reliance…
May 15, 2026

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Astrazeneca
NEWS

AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

Shots: The US FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause Approval was based on the P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks. Trial met…
May 15, 2026

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NEWS

Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Shots: Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism Processed on IDS’ random-access automation platforms, the expanded portfolio enables…
May 14, 2026

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NEWS

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT Trial showed a…
May 14, 2026

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NEWS

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…
May 14, 2026

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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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NEWS

Partner Therapeutics Reports the US FDA Approval of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The FDA has approved Partner Therapeutics' Bizengri (zenocutuzumab-zbco) under CNPV, for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion who progressed on or after prior systemic therapy Approval was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive advanced solid tumors, incl. cholangiocarcinoma (n=22, where 19 were…
May 11, 2026

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