Regulatory ApprovalsFDA Approves KERENDIA® (finerenone) for Heart Failure with LVEF ≥40%
The U.S. Food and Drug Administration (FDA) has approved KERENDIA® (finerenone) to treat heart failure (HF) with left ventricular ejection fraction (L...
Regulatory Approval
Regulatory Approvals
Regulatory ApprovalsDyne 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...
Regulatory ApprovalsSaptalis 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 ...
Regulatory ApprovalsNovartis Receives Approval for First Malaria Medicine for Newborns and Young Infants
Novartis announced that Coartem® (artemether-lumefantrine) Baby, also known as Riamet® Baby, has received approval from Swissmedic as the first malari...
Regulatory ApprovalsRelief 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...
Regulatory ApprovalsAmneal 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsFDA 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, ...
Regulatory ApprovalsDupixent 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 ...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsChina Approves HUTCHMED's ORPATHYS® and TAGRISSO® Combination for Lung Cancer
HUTCHMED announced that the China National Medical Products Administration (NMPA) approved the combination of ORPATHYS® (savolitinib) and TAGRISSO® (o...
Regulatory ApprovalsZemcelpro® 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsAktiia's Hilo Band: First Cuffless Blood Pressure Monitor Approved for OTC Use by FDA
Aktiia announced FDA 510(k) clearance for its cuffless blood pressure monitoring technology, marketed as the Hilo Band. This marks the first FDA clea...
Regulatory ApprovalsQurAlis 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...
Regulatory ApprovalsZevra Therapeutics Announces Presentations on MIPLYFFA® (arimoclomol) at Niemann-Pick Disease Conference
Zevra Therapeutics announced that MIPLYFFA® (arimoclomol), the first FDA-approved treatment for Niemann-Pick disease type C (NPC), will be featured in...
Regulatory ApprovalsCingulate'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...
Regulatory ApprovalsNeuspera 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...
Regulatory ApprovalsViridian 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 ...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsIpsen'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...
Regulatory ApprovalsTerumo 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...
Regulatory ApprovalsMadrigal 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsDupixent 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...
Regulatory ApprovalsENHERTU® 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...
Regulatory ApprovalsEmpNia Receives FDA Clearance for eMotus™ Respiratory Motion Management System
EmpNia Inc. announced FDA clearance for its eMotus™ system, a disposable sensor pad and software for managing respiratory motion in image-guided radia...
Regulatory ApprovalsMedian 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...
Regulatory ApprovalsFDA Approves Insightec's Exablate Neuro for Staged Bilateral Treatment of Parkinson's Disease
Insightec announced FDA approval of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson's ...
Regulatory ApprovalsModerna'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...
Regulatory ApprovalsFDA Grants Orphan Drug Designation to Klotho Neurosciences' KLTO-202 for ALS
Klotho Neurosciences announced that the FDA granted Orphan Drug Designation to its KLTO-202 (s-KL-AAV.myo) for the treatment of Amyotrophic Lateral Sc...
Regulatory ApprovalsInnoCare'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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsFDA 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...
Regulatory ApprovalsSoleno 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...
Regulatory ApprovalsFDA 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+)...
Regulatory ApprovalsFDA 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...
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