Regulatory ApprovalsCorcept Submits NDA for Relacorilant in Platinum-Resistant Ovarian Cancer
Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for relacorilant, a selective cortisol modulator, in combinat...
Regulatory Approval
Regulatory Approvals
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 ApprovalsProKidney Announces FDA Alignment on Accelerated Approval Pathway for Rilparencel
ProKidney announced FDA confirmation that the accelerated approval pathway for rilparencel, an autologous cellular therapy for chronic kidney disease ...
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 ApprovalsProtagonist Submits NDA for Icotrokinra, a Novel Oral Treatment for Plaque Psoriasis
Protagonist Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for icotrokinra, a first-in-class oral peptide for treati...
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 ApprovalsShanton Pharma's SAP-001 Receives FDA Fast Track Designation for Refractory Gout
Shanton Pharma announced that the FDA granted Fast Track designation to its investigational new drug, SAP-001, for treating hyperuricemia in adult gou...
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 ApprovalsPositive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment
BeOne Medicines announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recomme...
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 ApprovalsSanofi's SAR446523 Receives Orphan Drug Designation for Multiple Myeloma
Sanofi announced that the FDA granted orphan drug designation to SAR446523, a monoclonal antibody targeting GPRC5D, for the treatment of relapsed or r...
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 ApprovalsBioCardia Announces FDA and PMDA Regulatory Timeline for CardiAMP® Cell Therapy and Helix™ Catheter
BioCardia, Inc. announced its anticipated timeline for seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix™ Transendo...
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 ApprovalsDyne Therapeutics' DYNE-251 Receives FDA Breakthrough Therapy Designation for Duchenne Muscular Dystrophy
Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-251 for treating Duchenne muscular dystrophy (DMD) amenable ...
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 ApprovalsFDA Approves Papzimeos for Recurrent Respiratory Papillomatosis
The FDA has granted full approval to Precigen's Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with Recurrent Respiratory Papillom...
Regulatory ApprovalsTrinity Biotech Receives Regulatory Approval for PreClara™ Preeclampsia Test
Trinity Biotech plc announced that its New York reference laboratory received regulatory approval from the New York State Department of Health (NYSDOH...
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 ApprovalsLabcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease
Labcorp announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for Alzheimer's disea...
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 ApprovalsFDA Suspends License for Valneva's Chikungunya Vaccine IXCHIQ®
Valneva announced that the FDA has suspended the license for its chikungunya vaccine, IXCHIQ®, due to four new reports of serious adverse events (SAEs...
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 ApprovalsTeva Launches First Generic GLP-1 for Weight Loss: Liraglutide Injection
Teva Pharmaceuticals announced the FDA approval and US launch of its generic version of Saxenda® (liraglutide injection), the first generic glucagon-l...
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 ApprovalsAbbott's Navitor TAVI System Receives CE Mark for Expanded Aortic Stenosis Indication
Abbott announced that its Navitor transcatheter aortic valve implantation (TAVI) system received CE Mark approval in Europe for an expanded indication...
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 ApprovalsFDA Approves BILDYOS® and BILPREVDA®, Biosimilars to PROLIA and XGEVA
The US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to PROLIA and XGEVA, res...
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 ApprovalsOlomorasib Receives FDA Breakthrough Therapy Designation for KRAS G12C-Mutant Lung Cancer
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combin...
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 ApprovalsAgios Pharmaceuticals Announces PDUFA Date Extension for PYRUKYND® in Thalassemia
Agios Pharmaceuticals announced a three-month extension to the FDA's Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Ap...
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 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 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...
Regulatory ApprovalsEchosens and Novo Nordisk Partner to Improve MASH Diagnosis and Treatment
Echosens and Novo Nordisk are expanding their partnership to increase awareness and early diagnosis of metabolic dysfunction-associated steatohepatiti...
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