The US FDA Grants Priority Review to Bayer’s Kerendia for Chronic Kidney Disease Associated with Type 1 Diabetes

Shots: The US FDA has accepted sNDA & granted Priority Review to Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D) sNDA was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D Kerendia…

ByRidhi RastogiMay 21, 2026

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UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis

Shots: UCB has reported the (BE BOLD) trial data assessing Bimzelx(bimekizumab-bkzx) vs Skyrizi(risankizumab-rzaa) in 553 adults living with active psoriatic arthritis (PsA) Trial met its 1EP, with 49.1% pts achieving ACR50 at Wk. 16 vs 38.4%. The first ranked 2EP, MDA was numerically higher at Wk. 16 (43% vs 39.9%), but did not reach statistical…

ByRidhi RastogiMay 20, 2026

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Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management

Shots: Vincentage Pharma has reported topline P-III trial results evaluating VCT220 (120 0r 160mg, QD, PO) vs PBO for 52wks. in 840 Chinese adults with obesity or overweight with ≥1 weight-related comorbidity The trial met its 1EP, showing mean body weight reduction of -12.2% and -12.4% in the 120 & 160mg groups, respectively, vs -1.3% for…

ByRidhi RastogiMay 19, 2026

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AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension Trial met…

ByRidhi RastogiMay 18, 2026

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Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…

ByRidhi RastogiMay 18, 2026

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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…

ByRidhi RastogiMay 18, 2026

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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.…

ByRidhi RastogiMay 15, 2026

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MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Shots: MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…

ByRidhi RastogiMay 15, 2026

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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…

ByRidhi RastogiMay 15, 2026

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AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Shots: Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…

ByRidhi RastogiMay 14, 2026

The US FDA Grants Priority Review to Bayer’s Kerendia for Chronic Kidney Disease Associated with Type 1 Diabetes

UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis

Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

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

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

MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

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

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

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