FDA Approves Roche's Susvimo for Diabetic Retinopathy
The US Food and Drug Administration (FDA) has approved Roche's Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR). Susv...
May 23, 2025
ENHERTU® Receives Time-Limited Reimbursement in Canada for Gastric Cancer
AstraZeneca and Daiichi Sankyo announced that Canada's Drug Agency (CDA) has issued a Time-Limited Reimbursement (TLR) recommendation for ENHERTU® (tr...
May 23, 2025
FDA Approves Arcutis' ZORYVE Topical Foam for Plaque Psoriasis
Arcutis Biotherapeutics announced FDA approval of ZORYVE (roflumilast) topical foam 0.3% for treating plaque psoriasis in adults and adolescents (12+)...
May 23, 2025
FDA Approves Nucala for COPD Expansion
The FDA approved GSK's Nucala (mepolizumab), an anti-IL-5 antibody, for the treatment of chronic obstructive pulmonary disease (COPD). This approval e...
May 23, 2025
FDA Approves Genentech's Susvimo for Diabetic Retinopathy
Genentech announced FDA approval of Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR). Susvimo, delivered via a Port D...
May 23, 2025
FDA Approves Phraxis' EndoForce™ Connector for Dialysis Access
Phraxis Inc. announced FDA approval of its EndoForce™ Connector for Endovascular Venous Anastomosis, a medical device designed to simplify the creatio...
May 23, 2025
Saptalis Pharmaceuticals Launches LIKMEZ®, First FDA-Approved Ready-to-Use Metronidazole Oral Suspension
Saptalis Pharmaceuticals announced the launch of LIKMEZ® (metronidazole) oral suspension, the first and only US FDA-approved ready-to-use oral liquid ...
May 21, 2025
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
InnoCare's Mesutoclax Receives Breakthrough Therapy Designation in China
InnoCare Pharma announced that its BCL2 inhibitor, Mesutoclax (ICP-248), received Breakthrough Therapy Designation from China's NMPA for treating rela...
May 12, 2025
FDA and CDC Recommend Pause in IXCHIQ® Use for Elderly Individuals
Valneva announced that the FDA and CDC recommend pausing the use of their chikungunya vaccine, IXCHIQ®, in elderly individuals due to reported serious...
May 12, 2025
Viridian Therapeutics' Veligrotug Receives FDA Breakthrough Therapy Designation for Thyroid Eye Disease
Viridian Therapeutics announced that the FDA granted Breakthrough Therapy Designation to veligrotug, its lead drug candidate for treating Thyroid Eye ...
May 8, 2025
FDA Grants Orphan Drug Designation to JR-446 for Mucopolysaccharidosis Type IIIB
The U.S. Food and Drug Administration (FDA) granted orphan drug designation to JR-446, a drug developed by MEDIPAL HOLDINGS CORPORATION and JCR Pharma...
May 8, 2025
EMA Suspends IXCHIQ® Chikungunya Vaccine for Elderly Due to Adverse Events
The European Medicines Agency (EMA) has temporarily suspended the use of Valneva's chikungunya vaccine, IXCHIQ®, in individuals over 65 due to reports...
May 8, 2025
Adcentrx Therapeutics' ADRX-0706 Receives Fast Track Designation for Advanced Cervical Cancer
Adcentrx Therapeutics announced that the FDA granted Fast Track designation to its lead program, ADRX-0706, a Nectin-4 ADC, for treating locally advan...
