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June 13, 2025

Medtronic Announces MiniMed as Name for Planned New Diabetes Company

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FDA Grants Priority Review to Syndax's Revuforj® (revumenib) for Relapsed/Refractory mNPM1 AML

Syndax Pharmaceuticals announced that the FDA granted Priority Review to its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) to tre...

FDA Grants RMAT Designation to enGene's Detalimogene for High-Risk Bladder Cancer

enGene Holdings Inc. announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational therapy, det...

Dupixent Approved for Bullous Pemphigoid

The FDA has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), a chronic, debilitating, and rare skin disease. T...

Zemcelpro® Receives Positive CHMP Opinion for Blood Cancer Treatment

ExCellThera announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opin...

Madrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra) for MASH

Madrigal Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinio...

Relief Therapeutics' RLF-TD011 Denied QIDP Designation but Remains on Track for EB Treatment

Relief Therapeutics announced that its RLF-TD011, a hypochlorous acid solution for epidermolysis bullosa (EB), was not granted Qualified Infectious Di...

Ipsen's Cabometyx Receives Positive CHMP Opinion for Advanced Neuroendocrine Tumors

Ipsen announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Cabometyx (ca...

Dupixent Approved for Bullous Pemphigoid

The FDA has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), a chronic, debilitating, rare skin disease. This ...

FDA Approval of Keytruda for Head and Neck Cancer Highlights Potential for CEL-SCI's Multikine in PD-L1 Negative Patients

The FDA's approval of Merck's Keytruda for PD-L1 positive head and neck squamous cell carcinoma (HNSCC) based on interim Phase 3 data, sets a preceden...

Dyne Therapeutics Receives FDA Breakthrough Therapy Designation for DYNE-101 in Myotonic Dystrophy Type 1

Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-101 for treating myotonic dystrophy type 1 (DM1). This foll...

Neuspera Medical Receives FDA Approval for Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence

Neuspera Medical announced FDA approval of its integrated sacral neuromodulation (iSNM) system for treating urinary urge incontinence (UUI). This sys...

FDA Delays Sebetralstat NDA Decision Due to Resource Constraints

KalVista Pharmaceuticals announced that the FDA will not meet the June 17, 2025 PDUFA goal date for sebetralstat, an investigational oral on-demand tr...

FDA Approves IND Application for Myrio's PHOX2B PC-CAR T Therapy for Neuroblastoma

Myrio Therapeutics announced that the FDA approved its Investigational New Drug (IND) application for PHOX2B PC-CAR T, a chimeric antigen receptor (CA...

Amneal Receives FDA Approval for Prednisolone Acetate Ophthalmic Suspension

Amneal Pharmaceuticals announced FDA approval of its prednisolone acetate ophthalmic suspension 1%, a generic version of Pred Forte. This sterile, top...

Moderna's RSV Vaccine, mRESVIA, Receives FDA Approval for Expanded Use in Adults Aged 18-59

Moderna announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), its respiratory syncytial virus (RSV) vaccine, fo...

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...

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...

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+)...

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...

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...

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...

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 ...

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...

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...

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...

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...

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...

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, ...

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...

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...

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 ...

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...

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...

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...

FDA Accepts NDA for Oral Semaglutide 25mg for Obesity

Novo Nordisk announced that the FDA accepted its New Drug Application (NDA) for a 25 mg oral formulation of Wegovy (semaglutide) for chronic weight ma...

FDA Approves Atzumi™ for Acute Migraine Treatment

Satsuma Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Atzumi™ (dihydroergotamine (DHE)) nasal powder for the...