Merck Reports the P-IIb (MK-7240-012) Trial Data on Tulisokibart in Hidradenitis Suppurativa

Shots: Merck has presented the P-IIb (MK-7240-012) study data assessing tulisokibart vs PBO in pts with moderate to severe hidradenitis suppurativa at EADV’26 Trial met its 1EP, with HiSCR50 at Wk. 16 achieved by 72% pts on high-dose tulisokibart (480mg, Q2W) & 64% on medium-dose (480mg, Q4W), representing a 37% & 29% improvement over PBO…

ByRidhi Rastogi5 days ago

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Merck and SciBrunch Sign ~$2.13B Exclusive Global License Agreement for SPR2015

Shots: Merck & SciBrunch have entered into an exclusive global license agreement for SPR2015, with Merck receiving exclusive rights to develop, manufacture & commercialize SPR2015 worldwide As per the deal, SciBrunch will receive ~$400M upfront & payment associated with development, commercialization & other milestones across multiple indications, representing the total deal value of ~$2.13B SPR2015…

ByRidhi RastogiSeptember 28, 2026

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Merck and Eisai Report US FDA Approval of Welireg + Lenvima in Advanced Renal Cell Carcinoma

Shots: The US FDA has approved Welireg + Lenvima for the treatment of adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a PD-1 or PD-L1 inhibitor Approval was based on the P-III (LITESPARK-011) trial assessing Welireg (120mg, PO, QD) + Lenvima (20mg, PO, QD) vs cabozantinib in 747 pts with advanced…

ByRidhi RastogiSeptember 25, 2026

NEWS

Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Shots: Merck has reported the P-IIb/III (BRUNELLO) trial data assessing remigromig (MK-3000, formerly EYE103;0.5 & 0.8mg, IVT, Q4W) vs 0.5mg ranibizumab (Q4W) in 984 adults with diabetic macular edema (DME) At 52 wks., both remigromig doses demonstrated non-inferiority to 0.5mg ranibizumab in mean change from baseline in best-corrected visual acuity in pts with DME, with…

ByRidhi RastogiSeptember 25, 2026

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Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

Shots: Merck & Moderna have reported the P-III (INTerpath-001) trial data assessing adj. intismeran autogene (1mg, Q3W for 9 doses) + Keytruda (400mg, Q6W up to 9 cycles) vs Keytruda alone in 1,137 pts with high-risk (stage IIB-IV) resected cutaneous melanoma Intismeran plus Keytruda as adj. therapy showed improvements in RFS (1EP) and DMFS (2EP)…

ByRidhi RastogiAugust 19, 2026

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US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Shots: FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…

ByRidhi RastogiAugust 7, 2026

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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 RastogiJuly 17, 2026

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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 RastogiJuly 15, 2026

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Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…

ByRidhi RastogiJuly 13, 2026

NEWS

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Shots: The US FDA has approved Trodelvy + Keytruda/Keytruda Qlex for the 1L treatment of adults with inoperable, locally advanced, or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Approval was based on the P-III (ASCENT-04/KEYNOTE-D19) trial assessing Trodelvy (10mg/kg, IV, Day 1 & 8 of each 21-day cycle) + Keytruda (200mg, IV, Day 1 of…

ByRidhi RastogiJune 25, 2026

Merck Reports the P-IIb (MK-7240-012) Trial Data on Tulisokibart in Hidradenitis Suppurativa

Merck and SciBrunch Sign ~$2.13B Exclusive Global License Agreement for SPR2015

Merck and Eisai Report US FDA Approval of Welireg + Lenvima in Advanced Renal Cell Carcinoma

Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

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

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

Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

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