Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Shots: The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed…

ByRidhi Rastogi1 hour 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 RastogiJuly 16, 2026

NEWS

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

NEWS

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

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

NEWS

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 RastogiJune 26, 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

NEWS

AbbVie’s Maviret Receives EC Approval for Acute Hepatitis C Virus Infection

Shots: The EC has approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in pts (≥3yrs.) with compensated liver disease (with or without cirrhosis) Approval was based on the P-III (M20-350) trial assessing Maviret (QD, PO) in pts (≥12yrs.) with acute HCV infection, enrolling 286 treatment-naïve adults across 70 locations globally Trial…

ByRidhi RastogiJune 24, 2026

NEWS

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 RastogiJune 24, 2026

NEWS

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 RastogiJune 23, 2026

Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

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

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

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

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

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

AbbVie’s Maviret Receives EC Approval for Acute Hepatitis C Virus Infection

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

Contact US

FOLLOW US