CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

Shots: The US FDA has granted 510(k) clearance to PeriCross for controlled & efficient access to pericardial space through subxiphoid approach; US launch expected in coming mos., with select global expansion planned for 2026 Preliminary EASY-R trial data (enrolment completed) in 21 pts showed 100% access success, with mean access time of 3.5 ± 2.2min,…

ByRidhi RastogiApril 25, 2025

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VivaVision Biotech Reports Topline P-II Trial Data of VVN461 for Non-Infectious Anterior Uveitis

Shots: VivaVision has reported topline P-II trial data assessing 1.0% or 0.5% VVN461 (JAK1/TYK2 inhibitor) vs 1% prednisolone acetate (PA) for the treatment of non-infectious anterior uveitis in 86 Chinese pts for 28 days Trial demonstrated non-inferior efficacy to PA, achieving a 2-step ACC grade reduction (measured via SUN scale) as the 1EP & significant improvements…

ByRidhi RastogiApril 25, 2025

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AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

Shots: The US FDA has received BLA for TrenibotE (botulinum neurotoxin serotype E) for the treatment of mod. to sev. glabellar lines BLA was supported by 2 pivotal P-III (M21-500 & M21-508) trials & an open-label P-III (M21-509) safety study assessing TrenibotE in over 2,100 pts Trials met their 1 & 2EPs, with onset of…

ByRidhi RastogiApril 25, 2025

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Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal…

ByDipanshu DixitApril 25, 2025

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Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Shots: The US FDA has granted IND clearance to ATI-052 for the initiation of P-Ia/Ib trial The P-Ia/Ib trial assessing single & multiple ascending doses of ATI-052 followed by PoC portion in an undisclosed indication, is expected to begin in Q2’25 ATI-052 blocks upstream TSLP receptor signaling & downstream IL-4/IL-13 activation to inhibit a central…

ByRidhi RastogiApril 24, 2025

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Merck’s Keytruda Regimen Receives Health Canada’s Approval for Malignant Pleural Mesothelioma (MPM)

Shots: Health Canada has approved Keytruda + pemetrexed + Pt-based CT as 1L treatment of unresectable advanced or metastatic MPM based on P-II/III (IND.227/KEYNOTE-483) trial led by CCTG in collaboration with NCIN & IFCT Trial assessed the regimen in MPM pts (n=440) who received either Keytruda (200mg, IV) + pemetrexed (500mg/m^2) & Pt-based CT on Day…

ByRidhi RastogiApril 23, 2025

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Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…

ByRidhi RastogiApril 17, 2025

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Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Shots: The US FDA has approved Valtoco for short-term treatment of acute repetitive seizures (seizure clusters) in pts (≥2yrs.) with epilepsy Approval was based on P-I/IIa trial assessing safety & PK of Valtoco, which showed favorable safety & efficacy with easy administration in pts who had episodes of frequent seizures; data was presented at CNS…

ByRidhi RastogiApril 17, 2025

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Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Shots: Oak Hill Bio has entered into an exclusive license agreement with Roche to obtain global rights of rugonersen (RO7248824) for the treatment of angelman syndrome Oak Hill to initiate a pivotal P-III trial of rugonersen for angelman syndrome in early 2026, pending regulatory review of the final trial protocol TANGELO study led by Roche,…

ByRidhi RastogiApril 16, 2025

NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was…

ByRidhi RastogiApril 15, 2025

CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access

VivaVision Biotech Reports Topline P-II Trial Data of VVN461 for Non-Infectious Anterior Uveitis

AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Merck’s Keytruda Regimen Receives Health Canada’s Approval for Malignant Pleural Mesothelioma (MPM)

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Oak Hill Bio Enters an Exclusive Licensing Agreement with Roche for Rugonersen

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

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