Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Shots: The US FDA has approved Exzolt (fluralaner oral solution) to treat & control northern fowl mites (Ornithinyssus sylviarum) in chickens Exzolt is a parasiticide that targets the nervous system of northern fowl mites, killing those that ingest a blood meal, while remaining safe for laying hens & replacement chickens Exzolt, available in 1L &…

ByRidhi RastogiJuly 21, 2025

NEWS

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

ByRidhi RastogiJuly 21, 2025

NEWS

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

Shots: AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…

ByRidhi RastogiJuly 21, 2025

NEWS

ARS Pharmaceuticals and ALK’s EURneffy Secures the MHRA’s Approval to Treat Allergic Reactions in Children

Shots: The UK’s MHRA has approved EURneffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in children (>30kg); commercially available in the UK by late Q3’25 In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU (as EURneffy), Canada, & select markets in exchange for $145M upfront, ~$320M…

ByRidhi RastogiJuly 21, 2025

NEWS

The EC Grants Conditional Approval to SpringWorks Therapeutics’ Ezmekly for NF1-PN

Shots: The EC has granted conditional approval to Ezmekly (mirdametinib) for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR (52% & 41%) with durable…

ByRidhi RastogiJuly 21, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 14, 2025 – Jul 18, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below: Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1) Read More: Takeda AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…

ByRidhi RastogiJuly 18, 2025

NEWS

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathy Designation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…

ByRidhi RastogiJuly 18, 2025

NEWS

Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: The US FDA has granted BTD to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer Designation was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157) Trial showed improved PFS by 44% (mPFS: 40.7…

ByRidhi RastogiJuly 18, 2025

NEWS

NKGen Biotech Partners with HekaBio to Accelerate Troculeucel Development in Japan

Shots: NKGen Biotech has partnered with HekaBio to accelerate the regulatory, manufacturing & commercial development of troculeucel in Japan As per the collaboration, HekaBio will lead trials & handle regulatory activities with Japan’s PMDA for pre-market approval of troculeucel in neurodegenerative diseases, incl. Alzheimer’s & Parkinson’s. Also, HekaBio aims for first pts dosing in Japan…

ByRidhi RastogiJuly 18, 2025

NEWS

Keros Therapeutics Reports First Patient Dosing in P-III (RENEW) Trial of Elritercept for Transfusion-Dependent Anemia in Adults with MDS

Shots: Keros has dosed the first pts in P-III (RENEW) trial assessing elritercept vs PBO in adults with transfusion-dependent anemia with very low, low, or intermediate risk myelodysplastic syndromes (MDS) Dosing triggers a $10M milestone under Keros & Takeda’s Jan 2025 deal, in which Takeda gained global rights to develop, manufacture, & commercialize elritercept (excl.…

ByRidhi RastogiJuly 18, 2025

Ridhi Rastogi

Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

ARS Pharmaceuticals and ALK’s EURneffy Secures the MHRA’s Approval to Treat Allergic Reactions in Children

The EC Grants Conditional Approval to SpringWorks Therapeutics’ Ezmekly for NF1-PN

PharmaShots Weekly Snapshots (Jul 14, 2025 – Jul 18, 2025)

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Daiichi Sankyo Receives the US FDA’s Breakthrough Therapy Designation for Enhertu + Perjeta to Treat HER2+ Breast Cancer

NKGen Biotech Partners with HekaBio to Accelerate Troculeucel Development in Japan

Keros Therapeutics Reports First Patient Dosing in P-III (RENEW) Trial of Elritercept for Transfusion-Dependent Anemia in Adults with MDS

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