Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Shots: The US FDA has granted Orphan Drug Designation (ODD) to asedebart (Lu AG13909) for the treatment of endogenous Cushing's syndrome Lundbeck is evaluating efficacy and safety of asedebart in proof-of-concept trials for Cushing's disease & classic congenital adrenal hyperplasia (CAH) Asedebart is a humanized anti-ACTH monoclonal antibody that blocks ACTH signaling at the adrenal…

ByRidhi Rastogi14 hours ago

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Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Shots: Resolution Therapeutics has reported that the final patient has been treated in P-I/II (EMERALD) trial assessing RTX001 in patients with end-stage liver disease (ESLD) & a history of decompensated liver cirrhosis; Interim data are expected in the Q4’26 RTX001 is engineered with IL-10 & MMP-9 to enhance anti-inflammatory & anti-fibrotic effects of RMT, delivered…

ByRidhi Rastogi15 hours ago

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Nutromics Receives FDA Breakthrough Device Designation for Vancomycin TDM Patch

Shots: The US FDA has granted Breakthrough Device Designation to a wearable Vancomycin therapeutic drug monitoring (TDM) Patch, designed to continuously monitor vancomycin levels & support faster, more personalized dosing decisions In Feb 2026, Nutromics published first-in-human data on its molecular monitoring platform in Nature Biotechnology, plus the company has conducted ICU clinical studies in…

ByRidhi Rastogi16 hours ago

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Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Shots: The US FDA has granted IND clearance to initiate P-I trial of PRT13722 in HR+/HER2− breast cancer, with patient enrollment expected to begin in Q4’26 The P-I study will assess PRT13722’s safety, tolerability, PK, PD & antitumor activity as monotx. & in combination with endocrine or targeted therapies in adults with locally advanced/metastatic HR+/HER2−…

ByRidhi Rastogi18 hours ago

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Ocumension Therapeutics Reports NMPA NDA Acceptance of OT-301 to Lower Intraocular Pressure

Shots: The NMPA has accepted NDA for OT-301(bimatoprost grenod; NCX 470) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension The NDA was backed by the P-III (Mont Blanc & Denali) trial data, where Mont Blanc’s 1EP showed robust efficacy & safety, plus Denali met its 1EP of non-inferiority of OT-301 as…

ByRidhi Rastogi19 hours ago

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Johnson & Johnson Secures CE Mark Approval for ACUVUE OASYS MAX Reusable Contact Lenses

Shots: J&J has received CE Mark approval for Acuvue Oasys MAX 2-Week, a reusable contact lens featuring MAX technologies designed for superior comfort & visual clarity through day 14 Key features incl. OptiBlue Light Filter, which filters ≥60% blue-violet light, TearStable Tech that locks in moisture, & Class 1 UV blocking, when combined help to…

ByRidhi Rastogi20 hours ago

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Ethris Secures €30M Financing to Advance Respiratory mRNA Programs

Shots: Ethris, the European Investment Bank (EIB) & European Commission’s Health Emergency Preparedness and Response Authority (DG HERA) have signed a €30M financing agreement to advance Ethris’ respiratory mRNA portfolio The portfolio incl. ETH47 for asthma & COPD, and ETH52 & ETH53 for mucosal influenza vaccines & pandemic preparedness. The financing will support advancing ETH47…

ByRidhi Rastogi2 days ago

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Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

Shots: FDA has granted Priority Review to the sBLA of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a PDUFA target action date set for Jan 10, 2027. Filing is also under EMA’s review, with a decision expected in Q3’27 sBLA was supported by the P-III (METEOROID) trial data, assessing Enspryng(60,…

ByRidhi Rastogi2 days ago

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Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Shots: Japan’s MHLW has approved Shingrix in a PFS format (Recombinant Zoster Vaccine or RSV) for the prevention of shingles (herpes zoster) Approval was based on technical comparability between the PFS & existing vaccine presentation; the new presentation does not involve a change in indication or dosing Shingrix combines glycoprotein E with the AS01B…

ByRidhi Rastogi2 days ago

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Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

Shots: FDA has granted 510(k) clearance to Emboliner Embolic Protection System for use as an embolic protection device to capture & remove embolic material during transcatheter aortic valve replacement (TAVR), with phased commercial launch to begin later this year Clearance was backed by extensive clinical data, incl. the PROTECT H2H IDE study assessing Emboliner vs. Sentinel Cerebral…

ByRidhi Rastogi2 days ago

Ridhi Rastogi

Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Nutromics Receives FDA Breakthrough Device Designation for Vancomycin TDM Patch

Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Ocumension Therapeutics Reports NMPA NDA Acceptance of OT-301 to Lower Intraocular Pressure

Johnson & Johnson Secures CE Mark Approval for ACUVUE OASYS MAX Reusable Contact Lenses

Ethris Secures €30M Financing to Advance Respiratory mRNA Programs

Genentech Secures the US FDA Priority Review for Enspryng (Satralizumab) to Treat MOGAD

Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Emboline Receives US FDA 510(k) Clearance for Emboliner Embolic Protection System

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