Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: The US FDA has accepted NDA of vepdegestrant to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy (PDUFA: Jun 5, 2026) NDA was backed by P-III (VERITAC-2) trial assessing vepdegestrant alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed…

ByRidhi RastogiAugust 11, 2025

NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

ByRidhi RastogiAugust 11, 2025

NEWS

IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)

Shots: The CHMP has recommended Aqneursa (levacetylleucine) for treating adults & pediatric pts with NPC; additional global submissions are planned for 2025 & beyond Approval was backed by P-III (IB1001-301) study assessing Aqneursa vs PBO in pts (≥4yrs.; n=60) with NPC, which showed improved neurological symptoms & function across all 1 & 2EPs within 12wks.,…

ByRidhi RastogiJuly 30, 2025

NEWS

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Shots: The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25 Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute…

ByRidhi RastogiJuly 29, 2025

NEWS

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…

ByRidhi RastogiJuly 28, 2025

NEWS

KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The UK’s MHRA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.). Awaits approval in various global markets incl. the EU & Japan Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries, which showed faster symptom relief, reduced attack severity &…

ByRidhi RastogiJuly 16, 2025

NEWS

Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Shots: The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…

ByRidhi RastogiJuly 14, 2025

NEWS

KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediately Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE study KONFIDENT data was published in The NEJM, which showed…

ByRidhi RastogiJuly 7, 2025

NEWS

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…

ByRidhi RastogiJune 19, 2025

NEWS

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy NDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed improved PFS (1EP) by 43%…

ByRidhi RastogiJune 9, 2025

Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

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