J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The US FDA has approved Imaavy (nipocalimab-aahu) for the treatment of wAIHA in pts (≥12yrs.) currently or previously treated with corticosteroids Approval was based on the P-II/III (ENERGY) trial, which assessed 2 different dose schedules of Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts…

ByRidhi RastogiAugust 25, 2026

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Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The MHLW has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO) & RadiantLight randomized…

ByRidhi RastogiAugust 24, 2026

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Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Shots: The EC has approved Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.) across all 30 EEA states Approval was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale co-1EPs Daybu, a synthetic analog…

ByRidhi RastogiAugust 24, 2026

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Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

ByRidhi RastogiAugust 24, 2026

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Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

Shots: Merck & Moderna have reported the P-III (INTerpath-001) trial data assessing adj. intismeran autogene (1mg, Q3W for 9 doses) + Keytruda (400mg, Q6W up to 9 cycles) vs Keytruda alone in 1,137 pts with high-risk (stage IIB-IV) resected cutaneous melanoma Intismeran plus Keytruda as adj. therapy showed improvements in RFS (1EP) and DMFS (2EP)…

ByRidhi RastogiAugust 19, 2026

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Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…

ByRidhi RastogiAugust 18, 2026

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UroGen Submits NDA for UGN-103 to the US FDA for Recurrent LG-IR-NMIBC

Shots: The US FDA has received an NDA for UGN-103 (mitomycin; intravesical) to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) The NDA is supported by the P-III (UTOPIA) trial in adults with recurrent LG-IR-NMIBC, where UGN-103 achieved a 77.8% 3mos. CR rate & a 94.5% 6mos. DoR by Kaplan-Meier estimate, consistent…

ByRidhi RastogiAugust 18, 2026

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InnoCare Pharma Reports NMPA Approval for P-III Trial of Mesutoclax + Azacitidine in Treatment-Naive AML

Shots: Chinese NMPA has approved the P-III trial of mesutoclax (ICP-248) in combination with azacitidine vs venetoclax with azacitidine in elderly or unfit pts with treatment-naïve acute myeloid leukemia (TN AML) At ASCO’26, the combination achieved an 81.8% composite CR rate in evaluable TN AML pts (as of Apr 13, 2026), with 86.5% of responders…

ByRidhi RastogiAugust 18, 2026

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argenx Reports Topline P-III (ALKIVIA) Trial Data on Vyvgart Hytrulo in Autoimmune Myositis

Shots: The P-II/III (ALKIVIA) trial assessed Vyvgart Hytrulo (SC, QW) vs PBO PH20 (SC) for the treatment of pts (n=264) with autoimmune myositis across immune-mediated necrotizing myopathy (IMNM), dermatomyositis (DM) & PM The study met its 1EP, with Vyvgart Hytrulo delivering a 15.4-point greater improvement in mean TIS at Wk. 52 in IMNM & DM pts…

ByRidhi RastogiAugust 17, 2026

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HUTCHMED and AstraZeneca Report P-III (SAFFRON) Trial Data on Orpathys + Tagrisso for MET-Driven EGFRm Lung Cancer

Shots: The P-III (SAFFRON) trial assessed Orpathys (300mg; BID) + Tagrisso (80mg; QD) vs doublet Pt-based CT in 338 pts with EGFRm, LA/M NSCLC with MET overexpression or amplification whose disease progressed following 1 or 2L treatment with Tagrisso The trial showed a statistically significant & clinically meaningful improvement in both PFS & OS, with a favorable…

ByRidhi RastogiAugust 17, 2026

J&J Reports US FDA Approval of Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Takeda Reports MHLW Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

UroGen Submits NDA for UGN-103 to the US FDA for Recurrent LG-IR-NMIBC

InnoCare Pharma Reports NMPA Approval for P-III Trial of Mesutoclax + Azacitidine in Treatment-Naive AML

argenx Reports Topline P-III (ALKIVIA) Trial Data on Vyvgart Hytrulo in Autoimmune Myositis

HUTCHMED and AstraZeneca Report P-III (SAFFRON) Trial Data on Orpathys + Tagrisso for MET-Driven EGFRm Lung Cancer

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