EVERYONE has a heroic story to tell, their own legend to fulfill and HLTH is forging ahead into new realms of possibilities, gathering 12,000+ influential leaders, executives and visionaries who…
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PharmaShots speaks with Thomas Chalberg, Founder and CEO of Genascence Corporation, and Annahita Keravala, Founder and CSO of Genascence Corporation
Thomas and Annahita speak eloquently about Genascence's current lead…
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Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025
Robert Iannone, CMO, EVP, Global Head of Research and Development, and Chief Medical Officer…
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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…
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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…
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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…
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The US FDA has approved Genio system for pts with mod. to sev. obstructive sleep apnea (15 ≤ Apnea-Hypopnea Index ≤ 65); US commercialization is officially initiated
Approval was…
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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…
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The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic…
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…