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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

Protara Therapeutics Reports P-II (ADVANCED-2) Trial on TARA-002 in BCG-Naïve Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: Protara has reported 12mos. data from Cohort A of the ongoing P-II (ADVANCED-2) trial assessing TARA-002 in pts with carcinoma in situ or CIS (± Ta/T1) NMIBC who are BCG-Unresponsive or BCG-Naïve; P-III (ADVANCED-3)trialin BCG-Naïve pts to initiatein H2’26 The BCG-Naïve group (n=31), incl. 29 evaluable pts for efficacy, with 27 evaluable at 6mos.…
May 15, 2026

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NEWS

Resurge Therapeutics Presents Clinical Results on its Intraprostatic Drug Elution (IPDE) Platform for Benign Prostatic Hyperplasia (BPH) at AUA 2026

Shots: The 2 studies evaluated IPDE therapy for lower urinary tract symptoms (LUTS) secondary to BPH, assessing delivery of paclitaxel-eluting bioabsorbable implants through transperineal & transrectal approaches In the transperineal study (n=20), IPDE improved IPSS by 15 points & Qmax by ~4 mL/s at 1yr., achieving benefit in 80% pts, while the transrectal study (n=11)…
May 15, 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

Zydus to Acquire Assertio in ~$166.4M All-Cash Deal

Shots: Assertio Holdings’ Board has approved a definitive agreement with Zydus Worldwide DMCC, a subsidiary of Zydus, to acquire all outstanding Assertio shares, delisting it from the Nasdaq Assertio’s Board determined Zydus’ proposal constituted a “Superior Proposal” under the Garda merger agreement & authorized termination of the Garda transaction As per the deal, Zydus will…
May 14, 2026

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