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 Rastogi4 days ago

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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 Rastogi4 days ago

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OmniAb and Eli Lilly Partner on New Ion Channel Discovery Program

Shots: OmniAb has entered a global collaboration & license agreement with Eli Lilly for a new ion channel program, leveraging OmniAb’s discovery & screening platform to identify next-generation therapeutics targeting ion channels The therapeutic target and modality remain undisclosed, while OmniAb will contribute its established expertise and technology in ion channel discovery & screening As…

ByRidhi Rastogi5 days ago

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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 Rastogi5 days ago

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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 Rastogi5 days ago

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Daiichi Sankyo and AstraZeneca Report P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2 Mutant Non-Squamous NSCLC

Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs SoC (Pt-pemetrexed doublet CT + Keytruda) in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Trial showed that Enhertu improved PFS as 1L treatment, with trial continuing to evaluate 2EPs incl. OS;…

ByRidhi Rastogi5 days ago

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Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products

Shots: The deal incl. ~10 biosimilars or related components, incl. 3 initial assets: HLX05-N (cetuximab), HLX16 (evolocumab), & a proposed belimumab biosimilar, plus an option for HLXTE-HAase1001, a recombinant human hyaluronidase Sandoz will receive exclusive rights to register & commercialize the assets globally outside China, with both parties sharing development & lifecycle activities. Territories vary…

ByRidhi Rastogi5 days ago

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Lantheus Reports the US FDA Approval of Tauklarify as a PET Imaging Agent for Alzheimer’s Disease

Shots: The US FDA has approved Tauklarify (florquinitau F 18 injection/ MK-6240) for PET of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify pts with tau neurofibrillary tangle (NFT) pathology Approval was supported by Study 1 & 2 assessing Tauklarify (IV, 185 MBq) PET images from >500…

ByRidhi Rastogi5 days ago

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Rigel Reports Availability of Veppanu for ER+/HER2-, ESR1-Mutated Breast Cancer

Shots: Rigel has reported the availability of Veppanu (vepdegestrant) by prescription in the US for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following ≥1L of endocrine therapy Veppanu (200mg, PO, QD) is an FDA-approved PROTAC, a class of targeted protein degraders that uses the body’s natural machinery to…

ByRidhi RastogiAugust 14, 2026

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ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

Shots: The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU) The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials In…

ByRidhi RastogiAugust 14, 2026

Ridhi Rastogi

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

OmniAb and Eli Lilly Partner on New Ion Channel Discovery Program

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

Daiichi Sankyo and AstraZeneca Report P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2 Mutant Non-Squamous NSCLC

Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products

Lantheus Reports the US FDA Approval of Tauklarify as a PET Imaging Agent for Alzheimer’s Disease

Rigel Reports Availability of Veppanu for ER+/HER2-, ESR1-Mutated Breast Cancer

ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

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