Shorla Oncology's SH-110 Receives FDA Orphan Drug Designation for Glioma
Shorla Oncology announced that the FDA granted orphan drug designation to SH-110, an oral liquid formulation of a drug to treat glioma, a rare brain c...
July 16, 2025
ProKidney 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 ...
July 16, 2025
Vertex Pharmaceuticals Wins Innovation Award for JOURNAVX™, a Novel Non-Opioid Acute Pain Treatment
Vertex Pharmaceuticals announced that its non-opioid pain medication, JOURNAVX™ (suzetrigine), has been recognized as a groundbreaking healthcare tech...
July 15, 2025
Corcept 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...
July 15, 2025
Caranx Medical Receives FDA Clearance for AI-Powered Software Guiding Transcatheter Heart Valve Implantation
Caranx Medical announced FDA clearance for TAVIPILOT Soft, the world's first AI software for real-time intra-operative guidance of transcatheter aorti...
July 15, 2025
Sun Pharma Launches LEQSELVI™ (deuruxolitinib) for Severe Alopecia Areata in the U.S.
Sun Pharma announced the launch of LEQSELVI™ (deuruxolitinib) in the United States for the treatment of adults with severe alopecia areata. LEQSELVI ...
July 15, 2025
FDA Grants Fast Track Designation to Zenith's ZEN-3694 for NUT Carcinoma
Zenith Epigenetics announced that the FDA granted Fast Track designation to ZEN-3694, in combination with abemaciclib, for treating metastatic or unre...
July 14, 2025
FDA Rejects Ultragenyx's Gene Therapy for Sanfilippo Syndrome Due to Manufacturing Issues
Ultragenyx's investigational gene therapy, UX111, for Sanfilippo syndrome type A, was rejected by the FDA due to manufacturing concerns. The FDA's co...
July 14, 2025
EMA Lifts Restriction on Valneva's Chikungunya Vaccine IXCHIQ® for Elderly Patients
Valneva announced that the European Medicines Agency (EMA) has lifted the temporary restriction on using its single-dose chikungunya vaccine, IXCHIQ®,...
July 14, 2025
Zevra 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...
July 14, 2025
FDA 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...
July 14, 2025
FDA 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...
July 10, 2025
Aktiia'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...
July 10, 2025
FDA 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 ...
July 9, 2025
Novartis 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...
July 8, 2025
EmpNia 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...
July 1, 2025
China 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...
June 30, 2025
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...
June 25, 2025
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...
June 25, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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 ...
