Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

Shots: The US FDA has received NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. term neonates; MAA was submitted to MHLW with further filings planned in coming mos. NDA was supported by the QUANTI clinical program, which incl. 2…

ByRidhi RastogiJune 18, 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

NEWS

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots: China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapy NDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…

ByRidhi RastogiJune 5, 2025

NEWS

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026) NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial…

ByRidhi RastogiJune 2, 2025

NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Shots: The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025) NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with…

ByRidhi RastogiJune 2, 2025

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…

ByRidhi RastogiMay 27, 2025

NEWS

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…

ByRidhi RastogiMay 16, 2025

NEWS

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Shots: The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25 The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

ByRidhi RastogiMay 7, 2025

NEWS

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots: The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25) Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 2025

NEWS

Sebela Pharmaceuticals Reports Topline P-III (TRIUMpH) Program Data of Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consists of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE) & non-erosive reflux disease (NERD); EE’s maintenance phase to end by Q3’25, with FDA’s NDA filing for both EE & NERD planned in Q4’25 EE study (vs lansoprazole) in 1250 pts (incl. 463 with LA Grade C/D)…

ByRidhi RastogiApril 24, 2025

Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

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

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

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

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Sebela Pharmaceuticals Reports Topline P-III (TRIUMpH) Program Data of Tegoprazan for Gastroesophageal Reflux Disease (GERD)

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