Mission Therapeutics Inks a ~$292M Deal with Dimerix for MTX652

Shots: Mission Therapeutics has reported the divestment of its P-II-ready asset MTX652, to Dimerix for initial development in Acute Kidney Injury (AKI) As per the deal, Mission will receive ~$292M in upfront, development & commercial milestones, plus up to double-digit tiered royalties on global net sales The divestment aligns with Mission’s strategy to maximize its…

ByRidhi Rastogi9 hours ago

NEWS

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi Rastogi13 hours ago

NEWS

Merck Reports the US FDA Approval for Lipfendra (Enlicitide) to Reduce LDL-C in Adults with Hypercholesterolemia

Shots: The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from…

ByRidhi Rastogi14 hours ago

NEWS

Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management

Shots: The EC approved Wegovy pill (25mg, QD, PO) as an adjunct to lifestyle intervention for weight management in adults with obesity or overweight, with ≥1 weight-related condition; launch expected in H2’26. The EC also approved Wegovy 7.2mg injection in a single-dose pen for obesity Wegovy pill approval was based on the OASIS clinical trial…

ByRidhi Rastogi2 days ago

NEWS

Merck Reports P-III (KEYNOTE C93) Trial Data on Keytruda for Endometrial Cancer with dMMR Tumors

Shots: Merck has reported the P-III (KEYNOTE‑C93) trial assessing Keytruda (400mg, IV, Q6W for ~18 cycles) vs carboplatin + paclitaxel in pts (n=299) with dMMR advanced or recurrent endometrial cancer who have not previously been treated with systemic CT Trial met its 1EP of improved PFS, & showed improvements across ORR, CRR, & DoR; OS (1EP)…

ByRidhi Rastogi2 days ago

NEWS

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi Rastogi2 days ago

NEWS

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…

ByRidhi Rastogi3 days ago

NEWS

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

Shots: FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26 Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs…

ByRidhi Rastogi3 days ago

NEWS

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Shots: The US FDA has accepted NDA of mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027) NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd…

ByRidhi Rastogi4 days ago

NEWS

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Shots: The US has approved Sarclisa Escena (isatuximab-irfc; SC) + SoC for the treatment of pts with MM across all existing indications of Sarclisa IV formulation Approval was backed by multiple trials, incl. P-III (IRAKLIA) in R/R MM, which showed shorter treatment time & fewer infusion-related reactions with Sarclisa Escena In IRAKLIA, SC Sarclisa delivered…

ByRidhi Rastogi5 days ago

Mission Therapeutics Inks a ~$292M Deal with Dimerix for MTX652

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Merck Reports the US FDA Approval for Lipfendra (Enlicitide) to Reduce LDL-C in Adults with Hypercholesterolemia

Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management

Merck Reports P-III (KEYNOTE C93) Trial Data on Keytruda for Endometrial Cancer with dMMR Tumors

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

The US FDA Approves Sanofi’s Sarclisa Escena to Treat Multiple Myeloma (MM)

Contact US

FOLLOW US