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…

ByRidhi Rastogi4 days ago

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 &…

ByRidhi Rastogi4 days ago

News

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Shots:Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRTApproval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…

ByRidhi RastogiMay 22, 2025

News

Travere Therapeutics Reports the US FDA’s sNDA Acceptance of Filspari for Focal Segmental Glomerulosclerosis (FSGS)

Shots:The US FDA has accepted sNDA of Filspari for the treatment of FSGS, plus FDA has planned to hold advisory committee meeting to discuss the application (PDUFA: Jan 13, 2026)sNDA was supported by P-III (DUPLEX) trial & P-II (DUET) trial assessing Filspari vs irbesartan in FSGS pts; Pts completing the DUPLEX & DUET double-blind…

ByRidhi RastogiMay 16, 2025

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GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots:MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…

ByRidhi RastogiApril 21, 2025

News

Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:Health Canada has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRTApproval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi (for ~24mos.) vs PBOStudy showed reduced risk…

ByRidhi RastogiApril 11, 2025

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Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots:The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regionsTrial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…

ByRidhi RastogiApril 4, 2025

News

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots:Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapyApproval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

News

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots:The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

ByRidhi RastogiMarch 18, 2025

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

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

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Travere Therapeutics Reports the US FDA’s sNDA Acceptance of Filspari for Focal Segmental Glomerulosclerosis (FSGS)

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

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