Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

Shots: The US FDA has accepted NDA for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks (PDUFA: Apr 23, 2027) NDA was backed by data from >1,300 HAE attacks. In P-III (RAPIDe-3) trial, deucrictibant IR met the 1EP & all eleven 2EPs, with median times to symptom relief,…

ByRidhi RastogiJuly 6, 2026

NEWS

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Shots: The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure SkinTE is a first-in-class autologous…

ByRidhi RastogiJuly 3, 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

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Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…

ByRidhi RastogiJuly 2, 2026

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BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

BeOne has reported topline P-III (MANGROVE) trial results on Brukinsa (Zanubrutinib; 160mg, PO, BID) + rituximab vs bendamustine + rituximab in 510 adults with previously untreated mantle cell lymphoma The trial met its 1EP of improved PFS as assessed by IRC, leading to a 43% reduction in the risk of progression or death; OS (2EP) was immature…

ByRidhi RastogiJuly 1, 2026

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Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

Shots: CE Mark was based on the P-III (PANOVA-3) trial assessing Optune Pax used concomitantly with gem/nab-pac (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer, with launch expected in Germany in coming wks. Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In…

ByRidhi RastogiJuly 1, 2026

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AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Shots: The topline P-III (EPCORE DLBCL-4) trial results assessed epcoritamab + lenalidomide vs rituximab + gemcitabine + oxaliplatin (R-GemOx) in adults with R/R DLBCL who received ≥1L prior of therapy Trial met its 1EP, significantly improving PFS & reducing the risk of disease progression or death by 60% (US censoring) & 56% (ex-US censoring). AbbVie…

ByRidhi RastogiJune 30, 2026

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Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Shots: The US FDA has accepted sBLA & granted priority review to Roche's Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026 sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev.…

ByRidhi RastogiJune 30, 2026

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Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…

ByRidhi RastogiJune 30, 2026

NEWS

Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The CHMP has recommended Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Opinion was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…

ByRidhi RastogiJune 30, 2026

Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations

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