Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

Shots: The EC has granted ODD to ABO-101 for the treatment of primary hyperoxaluria ABO-101 is being evaluated in an open-label global P-I/II (redePHine) study assessing safety, tolerability, PK/PD, & preliminary efficacy of a single dose of ABO-101 in pts with PH type 1 ABO-101 is a one-time, liver-directed gene-editing therapy that uses an Acuitas-licensed…

ByRidhi Rastogi2 hours ago

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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 Rastogi3 hours ago

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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 Rastogi22 hours ago

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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 Rastogi1 day ago

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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 Rastogi2 days ago

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Gilead’s Trodelvy Receives the EC Approval for 1L Metastatic TNBC Patients Ineligible for PD-1/PD-L1 Inhibitor Therapy

Shots: The EC has approved Trodelvy monotx. as a 1L therapy for the treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy across all 30 EEA states Approval was backed by the P-III (ASCENT-03) trial showing a 38% reduced risk of disease progression or death in patients who are…

ByRidhi Rastogi2 days ago

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Arrowhead Pharmaceuticals Receives EC Approval for Redemplo to Treat Familial Chylomicronemia Syndrome

Shots: The EC has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with Familial Chylomicronemia Syndrome (FCS), backed by the P-III (PALISADE) trial assessing it (25 & 50mg, SC, Q3M) vs PBO in 75 FCS adults Trial met its 1 & all multiplicity-controlled key 2EPs. 25mg showed an 80% vs…

ByRidhi Rastogi3 days ago

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Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses

Shots: The EC has approved Cenrifki (PO, QD) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last 2yrs. Approval was backed by P-III (HERCULES) trial (vs PBO) in non-relapsing SPMS (nrSPMS) & supporting data from P-III (GEMINI 1 & 2) studies (vs teriflunomide) in relapsing MS, with HERCULES demonstrating delayed…

ByRidhi Rastogi3 days ago

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The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Shots: The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review Approval was based on the P-III (IRAKLIA) study in R/R…

ByRidhi RastogiJune 19, 2026

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Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

Shots: The MHLW has approved Minjuvi (tafasitamab) + Lenalidomide for the treatment of adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) Approval was based on the international P-II (L-MIND) trial, & a Japanese P-Ib/II (J-MIND) trial (Group 6) assessing Minjuvi + lenalidomide in pts with r/r DLBCL who are not eligible for autologous stem…

ByRidhi RastogiJune 19, 2026

Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria

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)

Gilead’s Trodelvy Receives the EC Approval for 1L Metastatic TNBC Patients Ineligible for PD-1/PD-L1 Inhibitor Therapy

Arrowhead Pharmaceuticals Receives EC Approval for Redemplo to Treat Familial Chylomicronemia Syndrome

Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R DLBCL

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