Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancer sNDA 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), which showed improved PFS by 44%,…

ByRidhi RastogiOctober 7, 2025

NEWS

Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Shots: Health Canada has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy under priority review Approval was based on VISION-DMD study, which met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at 24wks. of treatment, plus showed favorable safety & tolerability in pts Kye Pharma secured exclusive Canadian rights…

ByRidhi RastogiOctober 6, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:   Daiichi Sankyo & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer Read More: Daiichi Sankyo & AstraZeneca Merck Presents P-III (HYPERION) Trial Data…

ByRidhi RastogiOctober 3, 2025

NEWS

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Shots: The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide Approval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…

ByRidhi RastogiOctober 3, 2025

NEWS

AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

Shots: The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) The BLA is backed by the P-I/II (CADENZA) trial, which evaluated PVEK monotx. to establish the MTD, RP2D, & dosing schedule, while assessing safety, tolerability, PK, immunogenicity, & antileukemia activity in pts with CD123+…

ByRidhi RastogiOctober 1, 2025

NEWS

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…

ByRidhi RastogiOctober 1, 2025

NEWS

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in China Approval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…

ByRidhi RastogiOctober 1, 2025

NEWS

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitors BLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…

ByRidhi RastogiSeptember 30, 2025

NEWS

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Shots: The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025 The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…

ByRidhi RastogiSeptember 30, 2025

NEWS

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Shots: FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s label Plaque PsO approval was based…

ByRidhi RastogiSeptember 30, 2025

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 2025)

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

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