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Cingulate's CTx-1301 for ADHD: FDA Alignment on NDA Filing

Cingulate Inc. announced that it received positive feedback from the FDA regarding its pre-New Drug Application (NDA) meeting for CTx-1301, a novel on...

May 15, 2025

March 2024

Cingulate's CTx-1301 for ADHD: FDA Alignment on NDA Filing
Cingulate Inc. announced that it received positive feedback from the FDA regarding its pre-New Drug Application (NDA) meeting for CTx-1301, a novel on...
May 15, 2025
QurAlis Licenses Novel Mechanism for Fragile X Syndrome Treatment
QurAlis Corporation announced an exclusive license agreement with UMass Chan Medical School for a novel RNA-targeted mechanism to treat Fragile X synd...
May 15, 2025
Median Technologies Submits 510(k) Application for eyonis® LCS Lung Cancer Screening SaMD
Median Technologies announced the submission of a 510(k) application to the FDA for eyonis® LCS, an AI-powered software as a medical device (SaMD) for...
May 14, 2025
Soleno Therapeutics Presents VYKAT™ XR Data at ISPOR 2025 for Prader-Willi Syndrome
Soleno Therapeutics announced presentations at the ISPOR 2025 meeting featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets for the...
May 14, 2025
Terumo Neuro Launches SOFIA™ 88 Neurovascular Support Catheter in the US
Terumo Neuro announced the US commercial availability of the SOFIA™ 88 Neurovascular Support Catheter. This large-bore catheter is designed for relia...
May 14, 2025
FDA Clears United Imaging's uAngio® AVIVA Interventional X-Ray System
United Imaging announced FDA clearance for its uAngio® AVIVA interventional X-ray system. This ceiling-mounted system features intelligent robotics, ...
May 13, 2025

Feb 2024

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Latest Regulatory Approvals

Cingulate's CTx-1301 for ADHD: FDA Alignment on NDA Filing
May 15, 2025
QurAlis Licenses Novel Mechanism for Fragile X Syndrome Treatment
May 15, 2025
Median Technologies Submits 510(k) Application for eyonis® LCS Lung Cancer Screening SaMD
May 14, 2025
Soleno Therapeutics Presents VYKAT™ XR Data at ISPOR 2025 for Prader-Willi Syndrome
May 14, 2025
Terumo Neuro Launches SOFIA™ 88 Neurovascular Support Catheter in the US
May 14, 2025
FDA Clears United Imaging's uAngio® AVIVA Interventional X-Ray System
May 13, 2025
InnoCare's Mesutoclax Receives Breakthrough Therapy Designation in China
May 12, 2025
FDA and CDC Recommend Pause in IXCHIQ® Use for Elderly Individuals
May 12, 2025
Viridian Therapeutics' Veligrotug Receives FDA Breakthrough Therapy Designation for Thyroid Eye Disease
May 8, 2025
FDA Grants Orphan Drug Designation to JR-446 for Mucopolysaccharidosis Type IIIB
May 8, 2025
EMA Suspends IXCHIQ® Chikungunya Vaccine for Elderly Due to Adverse Events
May 8, 2025
Adcentrx Therapeutics' ADRX-0706 Receives Fast Track Designation for Advanced Cervical Cancer
May 7, 2025
FDA Accepts NDA for Oral Semaglutide 25mg for Obesity
May 2, 2025
FDA Approves Atzumi™ for Acute Migraine Treatment
May 1, 2025

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