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NEWS
Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis
Shots: Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA…
August 28, 20250Comments
NEWS
Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer
Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…
August 28, 20250Comments
NEWS
Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19
Shots: FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data…
August 28, 20250Comments
INSIGHTS+
Disease of the Month – Rosacea 
Shots:  Rosacea is a chronic skin condition characterized by facial redness, acne-like breakouts, and flushing. It may cause enlarged blood vessels and small pus pus-filled bumps   PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide. These reports provide a comprehensive overview of disease, including their…
August 27, 20250Comments