Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

Shots: The US FDA has accepted the sNDA & granted priority review to mitapivat, under FDA’s accelerated approval pathway, for the treatment of Sickle Cell Disease (PDUFA: Nov 1, 2026) sNDA was supported by the global P-II/III (RISE UP) trial assessing mitapivat (100mg, PO, BID; n=138) vs PBO (n=69) in 207 pts with SCD (≥16yrs.)…

ByRidhi RastogiJuly 7, 2026

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The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Shots: The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027) sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…

ByRidhi RastogiJune 16, 2026

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Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

Shots: Junshi Biosciences has reported the final analysis from the P-III (NEOTORCH) trial assessing toripalimab + Pt-containing doublet CT vs PBO + CT as perioperative treatment in 501 pts with resectable stage II-III NSCLC pts Trial improved EFS, with mEFS not reached vs 15.1mos. for CT alone, reducing risk of recurrence, progression, or death by 60%,…

ByRidhi RastogiMay 27, 2026

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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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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

Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

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

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