Skip to content Skip to footer
Subscribe Now
NEWS

Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: The US FDA has accepted NDA of vepdegestrant to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy (PDUFA: Jun 5, 2026) NDA was backed by P-III (VERITAC-2) trial assessing vepdegestrant alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed…
August 11, 2025

Read more

NEWS

CSL Receives Health Canada’s Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots:  Health Canada has approved Andembry (garadacimab) for HAE pts (≥12yrs) Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean; data was published in The Lancet Interim analysis of the ongoing OLE…
August 11, 2025

Read more

NEWS

GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

Shots: The US FDA has accepted sNDA & granted priority review to Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uncomplicated urogenital gonorrhoea (PDUFA: Dec 11, 2025); regulatory review is ongoing in the UK & Australia sNDA was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM)…
August 11, 2025

Read more

Novartis
NEWS

Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease

Shots: Novartis has reported topline P-III (NEPTUNUS-1 & 2) trial data assessing ianalumab (VAY736) in adults with active Sjögren's disease NEPTUNUS-1 assessed ianalumab (300mg, QM) vs PBO in 275 Sjögren's disease pts for 52wks. while NEPTUNUS-2 evaluated ianalumab (300mg; QM or Q3M) vs PBO for up to 52wks. in 504 pts; pts could then either…
August 11, 2025

Read more

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)  Read More: Roche   Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma  Read…
August 8, 2025

Read more

NEWS

Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Shots: A management-led syndicate, supported by global investors, will acquire a majority stake in HistoSonics for $2.25B The acquisition was led by K5 Global, Bezos Expeditions, Wellington Management, Alpha JWC Ventures, Venture Investors Health Fund, Lumira Ventures, & over 10 other private & public investors HistoSonics aims to expand its Edison histotripsy system beyond liver tumors…
August 8, 2025

Read more

Load more