Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

Shots: The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…

ByRidhi Rastogi7 hours ago

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uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Shots: The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database;…

ByRidhi Rastogi1 day ago

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Daiichi Sankyo and AstraZeneca Report EC Approval of Enhertu + Perjeta to Treat HER2+ Metastatic Breast Cancer

Shots: The EC has approved Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with unresectable or metastatic HER2+ (IHC 3+ or ISH+) breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior…

ByRidhi Rastogi2 days ago

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Zambon Secures the EC Approval for Hopledo to Treat Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The EC has approved Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Approval was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…

ByRidhi Rastogi3 days ago

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Takeda Reports the US FDA Approval of Mimrylo (Rusfertide) for Polycythemia Vera

Shots: The US FDA has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV) Approval was backed by the P-III (VERIFY) trial (n=293), which met all efficacy endpoints, showing higher response rates, reduced need for phlebotomy & improvement in fatigue as measured by PROMIS Fatigue Short Form 8a The VERIFY…

ByRidhi Rastogi4 days ago

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SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted Fast Track Designation (FTD) to SOT106 for the treatment of soft tissue sarcoma SOT106 is an ADC that targets LRRC15, a clinically validated target broadly expressed across multiple prevalent sarcoma subtypes, & has received FDA Orphan Drug Designation for osteosarcoma treatment SOTIO plans to initiate a first-in-human clinical trial of SOT106…

ByRidhi RastogiAugust 28, 2026

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The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

Shots: The FDA has accepted NDA for NCX 470 (bimatoprost grenod) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (PDUFA: Apr 30, 2027) The NDA, submitted by US licensee Kowa, is supported by P-III (Mont Blanc & Denali) trial data showing IOP reductions of up to 10mmHg with a favorable safety…

ByRidhi RastogiAugust 28, 2026

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AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

Shots: The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn's disease (CD) Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded…

ByRidhi RastogiAugust 27, 2026

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United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

Shots: The US FDA has accepted the NDA for ralinepag to treat pulmonary arterial hypertension, with PDUFA target action date of Jun 24, 2027 NDA was supported by the P-III (ADVANCE OUTCOMES) trial assessing ralinepag vs PBO in 687 patients with PAH, where pts who completed the trial had the option to enroll in ongoing…

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

Biogen and Eisai Report NMPA Approval of Leqembi (SC) as an Initiation Dose for Early Alzheimer’s Disease

uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Daiichi Sankyo and AstraZeneca Report EC Approval of Enhertu + Perjeta to Treat HER2+ Metastatic Breast Cancer

Zambon Secures the EC Approval for Hopledo to Treat Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Takeda Reports the US FDA Approval of Mimrylo (Rusfertide) for Polycythemia Vera

SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma

AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

United Therapeutics Reports the US FDA NDA Acceptance for Ralinepag to Treat Pulmonary Arterial Hypertension

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

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