Blog Band - Page 32 of 299

07

Aug 2025

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The…

07

Aug 2025

NEWS

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Shots: Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD) Trial will evaluate MAR001 (300,…

07

Aug 2025

NEWS

Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Shots: China’s NMPA has approved SonoVue for use in hysterosalpingo contrast sonography (HyCoSy) to detect tubal issues & uterine problems A meta-analysis of 24 studies in 1358 women with infertility…

07

Aug 2025

NEWS

Vertex Reports the P-II Study of VX‑993 in Acute Pain After Bunionectomy

Shots: Vertex announced topline results from its P‑II study of selective NaV1.8 inhibitor VX‑993 in 367 pts with acute pain post-bunionectomy; VX‑993 did not achieve a statistically significant improvement in…

06

Aug 2025

VIEWPOINTS

Healthcare Marketing: Tom Donnelly from Supreme Group in a Stimulating Dialogue Exchange with PharmaShots

Shots: Supreme Group recently announced its 8th acquisition, adding Nimble Works and Vital Works to its portfolio, strengthening its presence in healthcare marketing and communications The acquisition brings together Nimble…

06

Aug 2025

NEWS

Knight Therapeutics and Incyte Expand Latin America Agreement to Include Retifanlimab and Axatilimab

Shots: Knight Therapeutics has amended its agreement with Incyte Biosciences to gain exclusive distribution rights for retifanlimab (Brand name: Zynyz in the US and EU) and axatilimab (Brand name: Niktimvo…

06

Aug 2025

VIDEO

LIFE SCIENCES | DAILY NEWS | AUG 06, 2025 | PHARMASHOTS

06

Aug 2025

NEWS

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL) Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2)…

06

Aug 2025

NEWS

TransMedics Receives FDA Conditional IDE Approval to Initiate OCS ENHANCE Heart Study

Shots: TransMedics received US FDA conditional IDE approval to initiate its two-part Next‑Gen OCS ENHANCE Heart study evaluating prolonged heart perfusion (Part A) and superiority of OCS Heart in donation…

06

Aug 2025

NEWS

Jazz Pharmaceuticals Reports the US FDA’s Approval of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma

Shots: The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease…

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Vertex Reports the P-II Study of VX‑993 in Acute Pain After Bunionectomy

Healthcare Marketing: Tom Donnelly from Supreme Group in a Stimulating Dialogue Exchange with PharmaShots

Knight Therapeutics and Incyte Expand Latin America Agreement to Include Retifanlimab and Axatilimab

LIFE SCIENCES | DAILY NEWS | AUG 06, 2025 | PHARMASHOTS

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

TransMedics Receives FDA Conditional IDE Approval to Initiate OCS ENHANCE Heart Study

Jazz Pharmaceuticals Reports the US FDA’s Approval of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma

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