AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) +…

ByRidhi Rastogi1 hour ago

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Milestone Pharmaceuticals Reports the NMPA Approval of Etripamil Nasal Spray for PSVT

Shots: The NMPA has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults Approval was based on data from the global P-III (RAPID) trial & a Chinese P-III (JX02002) study. JX02002 met its 1EP, showing etripamil’s superiority over PBO in converting PSVT to sinus rhythm within 30min. NMPA approval triggered…

ByRidhi Rastogi3 days ago

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Ionis’ Zanvastro (Zilganersen) Receives US FDA Approval for Alexander Disease (AxD)

Shots: FDA has approved Zanvastro (50mg, Q3M, intrathecal injection) for the treatment of AxD in pediatric & adult pts, with launch expected in the coming wks. FDA also granted Ionis a Rare Pediatric Disease PRV Approval was backed by the Phase I-III trial assessing Zanvastro (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for…

ByRidhi Rastogi3 days ago

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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 Rastogi4 days 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 Rastogi5 days 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 RastogiSeptember 1, 2026

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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 RastogiAugust 31, 2026

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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 RastogiAugust 31, 2026

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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

AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Milestone Pharmaceuticals Reports the NMPA Approval of Etripamil Nasal Spray for PSVT

Ionis’ Zanvastro (Zilganersen) Receives US FDA Approval for Alexander Disease (AxD)

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

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