Shots: The first patient has been dosed in P-Ib trial evaluating SpringWorks’ Nirogacestat (GSI) + Janssen’s Teclistamab (Ab targeting BCMA and CD3) in patients with r/r MM. Janssen assumes all […]readmore
Tags : reports
Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult patients with r/r B-cell ALL […]readmore
Shots: The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN The study met its 1EPs and […]readmore
Shots: The NDA is based on the P-III EASE trial involves assessing Oleogel-S10 (filsuvez) vs control gel in patients with EB. The study met its 1EPs of accelerated healing of […]readmore
Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 in 583 adults at high […]readmore
Shots: The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml, SC) vs PBO in 20,000+ healthy children & adolescents aged 4-16yrs. to prevent dengue fever of any […]readmore
Shots: The P-III trial involves assessing REGEN-COV (casirivimab & imdevimab, 1200/2400mg, IV) vs PBO in non-hospitalized patients with COVID-19 The trial met its 1EPs i.e. showed a reduction in the […]readmore
Shots: The P-III trial will assess adjuvanted CoVLP formulation (two doses of 3.75µg, administered 21 days apart) vs PBO in ~30,000 subjects initially in healthy adults (18-65yrs.), followed by elderly […]readmore
Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at least one measurable solid tumor […]readmore
Shots: Genentech reports the new 2yrs. data from part 2 of SUNFISH study assessing Evrysdi vs PBO in people aged 2-25 years with Type 2 or Type 3 SMA Results: […]readmore