Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for 1L Treatment of Non-Squamous HER2-Mutated NSCLC

Shots: The US FDA has granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic non-squamous NSCLC harboring HER2/ERBB2 TKD-activating mutations Approval was supported by ORR & DoR results from the Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo in treatment-naïve…

ByRidhi Rastogi2 days ago

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Lee’s Pharm Licenses 1cBio’s OC-3 in China and Southeast Asia

Shots: 1cBio & Lee's Pharmaceutical have entered into a licensing agreement granting Lee's Pharm exclusive rights to develop & commercialize OC-3, a preclinical PARP1 inhibitor, in China & certain countries in SE Asia As per the deal, 1cBio will receive an upfront payment, development milestones & potential sales milestone payments totaling ~$27M, as well as…

ByRidhi Rastogi2 days ago

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Nanoscope Therapeutics Reports the US FDA BLA Acceptance of Mogenry for Retinitis Pigmentosa

Shots: The US FDA has accepted BLA of Mogenry (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration for pts with retinitis pigmentosa (RP) having severe vision loss BLA was supported by the P-I/IIa trial, & the P-IIb/III (RESTORE) trial, where RESTORE met its 1 & 2EPs, showing improvements in visual acuity at…

ByRidhi Rastogi3 days ago

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MannKind and Rose Pharma Partner to Develop ROSE-010 Technosphere for Weight Management

Shots: Rose received exclusive global rights to MannKind’s Technosphere tech to develop & commercialize ROSE-010 Technosphere, a rapid-acting GLP-1 receptor agonist, with initial work focused on formulation re-establishment & optimization, followed by nonclinical & regulatory development MannKind will receive equity in Rose Pharma, the right to receive royalties on potential future net sales & board…

ByRidhi Rastogi3 days ago

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BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

Shots: The P-II (QUINTESSENTIAL) trial assessed arlocabtagene autoleucel (arlo-cel) in r/r MM pts, who were previously treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy & a BCMA-targeted therapy The trial met its 1EP, showing improvement in ORR, & its key 2EP of CRR in the above-mentioned pts who had previously received ≥4L…

ByRidhi Rastogi3 days ago

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Pharvaris Reports the P-III (CHAPTER-3) Trial Data on Deucrictibant XR for Hereditary Angioedema (HAE)

Shots: Pharvaris has reported the P-III (CHAPTER-3) trial (N=85) assessing deucrictibant XR tablet (40mg, QD, PO; n=55) vs PBO (n=30) for the prevention of attacks in adolescents & adults with HAE Trial met all 1 & 2EPs, reducing monthly mean HAE attack rates by 83% overall & 87% in Type 1 or 2 HAE (n=80),…

ByRidhi Rastogi3 days ago

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Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

Shots: The US FDA has approved TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with challenging cases of atrial fibrillation (AFib) Approval was based on the results from Abbott's FlexPulse IDE study, with data recently presented at the ESC’26 & simultaneously published in EPEuropace, showing favorable safety & effectiveness outcomes in pts with paroxysmal AFib TactiFlex Duo delivers…

ByRidhi Rastogi3 days ago

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Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

Shots: Amgen & AZ have reported the P-III (DeLLphi-305) trial data assessing Imfinzi + Imdelltra vs Imfinzi as the 1L maintenance treatment for pts (n=563) with ES-SCLC who have not progressed following induction treatment with Imfinzi + PT-based CT & etoposide Trial showed improved OS (1EP) & demonstrated benefits across 2EPs, incl. PFS & ORR;…

ByRidhi Rastogi3 days ago

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Rezubio Reports First Cohort Dosing in P-I Trial of RZ-520 Following FDA and NMPA IND Clearances

Shots: Rezubio has completed dosing of the first cohort in its P-I trial of RZ-520, following US FDA & Chinese NMPA clearances to assess its safety, tolerability, PK & PD in healthy volunteers RZ-520 is a clinical-stage asset developed using Rezubio’s MADD platform, with preclinical studies showing robust efficacy, superior safety & negligible systemic exposure…

ByRidhi Rastogi5 days ago

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Novo Nordisk Reports the P-III (STEP Young) Trial Data on Semaglutide to Treat Children Living with Obesity

Shots: Novo Nordisk has reported the P-III (STEP Young) trial data assessing semaglutide (1.7 or 2.4mg based on weight at start of trial; QW, SC) vs PBO in 165 children (6 to <12yrs.) with obesity, both in combination with a reduced-calorie diet & increased physical activity Trial met its 1EP of superior BMI reduction at…

ByRidhi Rastogi5 days ago

Ridhi Rastogi

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for 1L Treatment of Non-Squamous HER2-Mutated NSCLC

Lee’s Pharm Licenses 1cBio’s OC-3 in China and Southeast Asia

Nanoscope Therapeutics Reports the US FDA BLA Acceptance of Mogenry for Retinitis Pigmentosa

MannKind and Rose Pharma Partner to Develop ROSE-010 Technosphere for Weight Management

BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

Pharvaris Reports the P-III (CHAPTER-3) Trial Data on Deucrictibant XR for Hereditary Angioedema (HAE)

Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

Rezubio Reports First Cohort Dosing in P-I Trial of RZ-520 Following FDA and NMPA IND Clearances

Novo Nordisk Reports the P-III (STEP Young) Trial Data on Semaglutide to Treat Children Living with Obesity

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