Skip to content Skip to footer
Subscribe Now
Incyte
NEWS

The US FDA Approves Incyte’s Zynyz to Treat Adults with Squamous Cell Anal Carcinoma (SCAC)

Shots: FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…
May 16, 2025

Read more

Abbvie
NEWS

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots: The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC  Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…
May 16, 2025

Read more

Cytokinetics
NEWS

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Shots: Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review  The trial met its 1EP, showing superior improvement in peak oxygen…
May 14, 2025

Read more

Lenz Therapeutics and Lotus
NEWS

LENZ Therapeutics Collaborates with Lotus Pharmaceutical to Commercialize LNZ100 in the Republic of Korea and Southeast Asia

Shots: LENZ has granted Lotus exclusive development, manufacturing, registration & marketing rights of LNZ100 to treat presbyopia in the Republic of Korea & certain Southeast Asian countries incl. Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia & Singapore As per the deal, LENZ will obtain ~$125M in upfront, regulatory & commercial milestones, along with double-digit net sales-based…
May 12, 2025

Read more

Astrazeneca
NEWS

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapy Imfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…
May 12, 2025

Read more

ALK
NEWS

ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis

Shots: Health Canada has approved Itulatek (tree pollen sublingual tablet) to treat mod. to sev. seasonal allergic rhinitis &/or conjunctivitis, induced by pollen from birch, alder, hazel, &/or oak in pts (5-17yrs.); applications under the Swissmedic & MHRA’s review, with decision expected this year Approval was based on P-III (TT-06) trial assessing Itulatek vs PBO…
May 9, 2025

Read more

Load more