Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…

ByRidhi RastogiJanuary 13, 2026

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Pfizer Reports P-III (BREAKWATER) Trial Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved ORR (64.4% vs 39.2%), with 57.4% vs 34.5% achieving ≥6mos. responses; mDoR was not…

ByRidhi RastogiJanuary 12, 2026

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Annexon Seeks European Approval of Tanruprubart for Guillain-Barré Syndrome

Shots: The EMA has received MAA of tanruprubart for the treatment of Guillain-Barré syndrome (GBS) The MAA dossier demonstrated rapid neuroinflammation control & improved recovery, supported by a PoC study & a P-III trial against PBO, favorable risk/benefit, robust US & Southeast Asian biomarker data, PK (US/EU/SE Asia), & RWE matching P-III outcomes to IVIg…

ByRidhi RastogiJanuary 9, 2026

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GSK Reports P-III (B-Well 1 & B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B

Shots: GSK has reported P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in over 1,800 pts from 29 countries for the treatment of chronic hepatitis B (CHB) Both trials met the 1EP, with bepirovirsen delivering a statistically significant, clinically meaningful functional cure & showing superior cure rates vs SoC; Results were…

ByRidhi RastogiJanuary 8, 2026

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Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC

Shots: Merck has initiated P-III (KANDLELIT-007) trial of calderasib (MK-1084) + Keytruda Qlex for the 1L treatment of pts with KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC Trial will assess calderasib (PO, QD) + Keytruda Qlex (SC; Q6W) vs Keytruda Qlex + pemetrexed (IV) + CT in ~ 675 newly diagnosed pts with KRAS G12C-mutant nonsq. NSCLC, evaluating PFS as 1EP…

ByRidhi RastogiJanuary 8, 2026

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Jazz Pharmaceuticals to Highlight P-III (HERIZON-GEA-01) Trial Data on Ziihera (Zanidatamab-hrii) for Gastroesophageal Adenocarcinoma (GEA) at ASCO 2026

Shots: The P-III (HERIZON-GEA-01) trial assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as the 1L treatment in 914 adults with HER2+ locally advanced or metastatic GEA Ziihera + CT & Ziihera + Tevimbra + CT showed prolonged PFS with 35% risk reduction delivering mPFS of 12.4mos., with mOS of 24.4 & 26.4mos., respectively,…

ByRidhi RastogiJanuary 7, 2026

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GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

Shots: GSK’s Exdensur was approved for sev. or refractory bronchial asthma unresponsive to existing therapies & for CRSwNP in pts whose disease remains inadequately controlled with SoC, based on the P-III (SWIFT & ANCHOR) trials, respectively; filings under regulatory review in the EU & China SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma…

ByRidhi RastogiJanuary 6, 2026

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Takeda and Protagonist Therapeutics Report the US FDA’s NDA Submission for Rusfertide to Treat Polycythemia Vera

Shots: The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV) NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response…

ByRidhi RastogiJanuary 6, 2026

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Arrowhead Pharmaceuticals Receives the Health Canada Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: Health Canada has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS who had an inadequate response to standard triglyceride lowering therapies Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts…

ByRidhi RastogiJanuary 6, 2026

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Incyte Reports the Topline P-III (frontMIND) Trial Data on Monjuvi (Tafasitamab) Combination for Diffuse Large B-Cell Lymphoma

Shots: The P-III (frontMIND) trial assessed Monjuvi (Minjuvi in EU) + lenalidomide & R-CHOP vs R-CHOP as the 1L treatment in ~900 adults with previously untreated DLBCL (IPI score of 3-5 for pts >60yrs or aaIPI of 2-3 for pts ≤60yrs.) Trial met its 1EP of improved PFS by investigator assessment & achieved its key…

ByRidhi RastogiJanuary 6, 2026

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Pfizer Reports P-III (BREAKWATER) Trial Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Annexon Seeks European Approval of Tanruprubart for Guillain-Barré Syndrome

GSK Reports P-III (B-Well 1 & B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B

Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC

Jazz Pharmaceuticals to Highlight P-III (HERIZON-GEA-01) Trial Data on Ziihera (Zanidatamab-hrii) for Gastroesophageal Adenocarcinoma (GEA) at ASCO 2026

GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

Takeda and Protagonist Therapeutics Report the US FDA’s NDA Submission for Rusfertide to Treat Polycythemia Vera

Arrowhead Pharmaceuticals Receives the Health Canada Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Incyte Reports the Topline P-III (frontMIND) Trial Data on Monjuvi (Tafasitamab) Combination for Diffuse Large B-Cell Lymphoma

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