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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 &…
July 16, 2025

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Bayer
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…
July 14, 2025

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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…
July 7, 2025

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Gilead
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…
June 19, 2025

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Arvinas and Pfizer
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%…
June 9, 2025

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Bayer
NEWS

Bayer Presents P-III (OASIS 4) Study Data of Elinzanetant for Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies at ASCO 2025

Shots: The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regions Trial showed reduced VMS frequency (1EP), with…
June 3, 2025

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GSK New
NEWS

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled CRSwNP based on P-III (SWIFT & ANCHOR) trials, respectively    SWIFT-1 (n=382) & SWIFT-2 (n=380) trials assessed depemokimab vs PBO + SoC, ICS & controller…
May 27, 2025

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Autolus
NEWS

Autolus Therapeutics’ Obecabtagene Autoleucel Receives the CHMP’s Positive Opinion for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The CHMP has recommended Obecabtagene Autoleucel (obe-cel; autologous CD19 CAR T cell therapy) for treating pts (≥26yrs.) with r/r B-ALL; EC’s decision on conditional MAA is expected within 2mos. Opinion was based on the P-Ib/II (FELIX) study assessing obe-cel in over 100 adults with r/r B-cell precursor ALL across 30 sites in the US, UK &…
May 27, 2025

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