AbbVie and Genmab Report EC Approval of Tepkinly Combination to Treat R/R Follicular Lymphoma

Shots: The EC has approved Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (Tepkinly + R2) for the treatment of adults with R/R follicular lymphoma (FL) Approval was based on the P-III (EPCORE FL-1) trial assessing fixed-duration Tepkinly + R2 (n=243) vs SoC R2 (n=245) in pts with R/R FL following ≥1 prior line of treatment Trial…

ByRidhi RastogiJuly 7, 2026

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Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Shots: The EC has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the…

ByRidhi RastogiJuly 2, 2026

NEWS

Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Shots: The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…

ByRidhi RastogiJuly 1, 2026

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The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors

Shots: Enhertu approval for previously treated adults with unresectable or metastatic HER2+ (IHC 3+) solid tumors & no satisfactory treatment option, was based on subgroup data from P-II trials, incl. DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. In DESTINY-PanTumor02, Enhertu achieved a cORR of 52.3% & mDOR of 21.1mos. in previously treated HER2+ solid tumors (n=111), while DESTINY-Lung01 reported a cORR of…

ByRidhi RastogiJune 29, 2026

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Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

ByRidhi RastogiJune 29, 2026

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Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The CHMP has recommended Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Opinion was backed by the global P-III (TROPION-Breast02)…

ByRidhi RastogiJune 26, 2026

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Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Shots: The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026 Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO…

ByRidhi RastogiJune 26, 2026

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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

NEWS

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…

ByRidhi RastogiJune 25, 2026

NEWS

Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC across all 30 EEA states Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)…

ByRidhi RastogiJune 24, 2026

AbbVie and Genmab Report EC Approval of Tepkinly Combination to Treat R/R Follicular Lymphoma

Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

The EC Approves Daiichi Sankyo and AstraZeneca’s Enhertu for Previously Treated HER2+ Metastatic Solid Tumors

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

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

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

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