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 Rastogi4 days ago

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Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…

ByRidhi RastogiMay 19, 2026

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argenx Reports the US FDA Approval of Vyvgart and Vyvgart Hytrulo for Generalized Myasthenia Gravis

Shots: The US FDA has approved the label expansion of argenx's Vyvgart (efgartigimod alfa-fcab) & Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) for the treatment of adult pts with gMG, expanding its use in all serotypes of gMG Approval was based on the P-III (ADAPT SERON) study assessing efgartigimod vs PBO in gMG pts (n=119) who…

ByRidhi RastogiMay 11, 2026

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Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…

ByRidhi RastogiMay 4, 2026

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LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

Shots: The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…

ByRidhi RastogiApril 16, 2026

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IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia

Shots: The US FDA has received sNDA of Aqneursa (levacetylleucine) for the treatment of Ataxia-Telangiectasia (A-T) sNDA was backed by the P-III trial assessing Aqneursa in adult and pediatric pts with A-T, which met its 1 & key 2EPs & showed that Aqneursa has a favorable safety profile Aqneursa was previously approved by both the…

ByRidhi RastogiMarch 23, 2026

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Merck and Eisai Present P-III (LITESPARK-011) Trial Data on Welireg + Lenvima in Advanced Renal Cell Carcinoma (RCC) at ASCO GU 2026

Shots: Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…

ByRidhi RastogiMarch 3, 2026

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Merck Presents P-III (LITESPARK-022) Trial Data on Keytruda + Welireg in Clear Cell Renal Cell Carcinoma (RCC) at ASCO GU 2026

Shots: Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy At 28.4mos. mFU, the trial showed improved DFS (1EP), reducing the risk of disease recurrence or death by 28%, with mDFS…

ByRidhi RastogiMarch 2, 2026

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Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Shots: The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026 sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults…

ByRidhi RastogiFebruary 27, 2026

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Novartis Reports Topline P-III (RemIND) Trial Results on Remibrutinib in Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial met its 1EP for the three prevalent subtypes of CIndU, incl. symptomatic dermographism, cold urticaria, & cholinergic urticaria, delivering significantly higher complete response rates at Wk. 12 Additionally, Novartis has submitted…

ByRidhi RastogiFebruary 18, 2026

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

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

argenx Reports the US FDA Approval of Vyvgart and Vyvgart Hytrulo for Generalized Myasthenia Gravis

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia

Merck and Eisai Present P-III (LITESPARK-011) Trial Data on Welireg + Lenvima in Advanced Renal Cell Carcinoma (RCC) at ASCO GU 2026

Merck Presents P-III (LITESPARK-022) Trial Data on Keytruda + Welireg in Clear Cell Renal Cell Carcinoma (RCC) at ASCO GU 2026

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Novartis Reports Topline P-III (RemIND) Trial Results on Remibrutinib in Chronic Inducible Urticaria (CIndU)

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