Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Shots: The US FDA has accepted sNDA & granted priority review to AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation (PDUFA: April 30, 2026) The sNDA reflects AXS-05’s clinical development program in Alzheimer’s disease agitation, which included four randomized, double-blind P-III trials and a long-term safety study AXS-05 is an oral investigational…

ByDipanshu DixitJanuary 1, 2026

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FibroBiologics Submits IND Application with the US FDA for CYPS317 in Patients with Psoriasis

Shots: The company has filed a P-I/II IND with the FDA to begin clinical trials of CYPS317 for mod. to sev. Psoriasis In animal studies, a single dose of CYPS317 matched or exceeded multiple anti-IL-23 mAb doses, showing durable effects and reduced disease recurrence CYPS317 is an investigational allogeneic fibroblast spheroid therapy for mod. to…

ByDipanshu DixitJanuary 1, 2026

NEWS

Ultragenyx Completes FDA Rolling BLA Submission for DTX401 in Glycogen Storage Disease Type Ia (GSDIa)

Shots: Ultragenyx has completed rolling submission of a BLA to the FDA seeking approval of DTX401 (pariglasgene brecaparvovec) for the treatment of GSDIa BLA is supported by data from 52 pts with 6yrs. of follow-up. Previously reported P-III (GlucoGene) trial results showed significant reductions in both quantity & frequency of daily cornstarch intake, improved euglycemia…

ByRidhi RastogiDecember 31, 2025

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Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion

Shots: The US FDA has granted Nereus for the prevention of vomiting induced by motion, backed by 3 trials, incl. 2 P-III real-world boat studies (Motion Syros & Motion Serifos) & 1 supporting study in pts with documented motion sickness In Motion Syros (n=365) & Motion Serifos (n=316), vomiting incidence was 18.3–19.5% & 10.4–18.3% vs 44.3%…

ByRidhi RastogiDecember 31, 2025

NEWS

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Savolitinib for Gastric Cancer Patients with MET Amplification

Shots: The Chinese NMPA has accepted NDA & granted priority review to savolitinib for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments NDA was supported by the P-II trial of savolitinib in gastric cancer pts with MET amplification in China, which met its 1EP of improved ORR by…

ByRidhi RastogiDecember 30, 2025

NEWS

INOVIO Reports the US FDA’s BLA Acceptance of INO-3107 for Recurrent Respiratory Papillomatosis (RRP)

Shots: The US FDA has accepted BLA of INO-3107 for the treatment for adults with RRP, granting PDUFA target action date of Oct 30, 2026 INOVIO filed a BLA for INO-3107 under the accelerated approval pathway & plans to engage with the FDA to align on requirements, while confirming it is not pursuing approval under…

ByRidhi RastogiDecember 30, 2025

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Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Shots: The US FDA has granted BTD to ulixacaltamide for the treatment of patients with essential tremor (ET) Designation was based on the topline data from the Essential3 program, consisting of Study 1 & 2, where in Study 1, ulixacaltamide improved mADL11 (1EP) by 4.3 points at Wk. 8, while Study 2 showed superior maintenance of…

ByRidhi RastogiDecember 30, 2025

NEWS

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

Shots: The Chinese NMPA has approved neffy 2mg for the emergency treatment of type I allergic reactions (anaphylaxis) in adults & children (≥30kg), with availability anticipated in the spring of 2026. Filing for neffy 1mg for children (15 to <30kg) to the NMPA is expected in the coming mos. In 2021, ARS Pharma licensed neffy…

ByRidhi RastogiDecember 30, 2025

NEWS

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Shots: The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapy NDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, …

ByRidhi RastogiDecember 29, 2025

NEWS

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Shots: Chinese NMPA received two IND applications for CT0596 to initiate P-Ib/II trials in r/r multiple myeloma (MM) & primary plasma cell leukemia (pPCL), respectively IIT in China showed favorable efficacy as of Aug 31, 2025, with 6/8 evaluable R/R MM pts achieving PR or better (3 CR/sCR, 1 VGPR, 2 PR) at an mFU…

ByRidhi RastogiDecember 29, 2025

Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

FibroBiologics Submits IND Application with the US FDA for CYPS317 in Patients with Psoriasis

Ultragenyx Completes FDA Rolling BLA Submission for DTX401 in Glycogen Storage Disease Type Ia (GSDIa)

Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Savolitinib for Gastric Cancer Patients with MET Amplification

INOVIO Reports the US FDA’s BLA Acceptance of INO-3107 for Recurrent Respiratory Papillomatosis (RRP)

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

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