Regulatory Approvals18 Aug 2025
Echosens and Novo Nordisk are expanding their partnership to increase awareness and early diagnosis of metabolic dysfunction-associated steatohepatiti...
Regulatory Approvals18 Aug 2025
The FDA has granted full approval to Precigen's Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with Recurrent Respiratory Papillom...
Regulatory Approvals18 Aug 2025
AstraZeneca has launched FluMist Home, a first-of-its-kind at-home delivery service for its FLUMIST® (Influenza Vaccine Live, Intranasal) nasal spray ...
Regulatory Approvals18 Aug 2025
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 Approvals18 Aug 2025
Novo Nordisk announced that the FDA has approved Wegovy® (semaglutide 2.4 mg) for the treatment of noncirrhotic metabolic dysfunction-associated steat...
Regulatory Approvals15 Aug 2025
Trinity Biotech plc announced that its New York reference laboratory received regulatory approval from the New York State Department of Health (NYSDOH...
Regulatory Approvals14 Aug 2025
DeepSight Technology announced FDA 510(k) clearance for its NeedleVue™ LC1 Ultrasound System. This system, along with the company's NeedleVue™ and OnP...
Regulatory Approvals05 Aug 2025
Agios Pharmaceuticals announced that the Saudi Food and Drug Authority (SFDA) has approved PYRUKYND® (mitapivat) for treating adult patients with non-...
Regulatory Approvals05 Aug 2025
Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-251 for treating Duchenne muscular dystrophy (DMD) amenable ...
Regulatory Approvals04 Aug 2025
BioCardia, Inc. announced its anticipated timeline for seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix™ Transendo...
Regulatory Approvals30 Jul 2025
Sanofi announced that the FDA granted orphan drug designation to SAR446523, a monoclonal antibody targeting GPRC5D, for the treatment of relapsed or r...
Regulatory Approvals30 Jul 2025
AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for a fixed-duration, all-oral combination of VENCLEXTA (venetoclax) and acalab...
Regulatory Approvals29 Jul 2025
Deciphera Pharmaceuticals and Ono Pharmaceutical announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) ...
Regulatory Approvals28 Jul 2025
Shanton Pharma announced that the FDA granted Fast Track designation to its investigational new drug, SAP-001, for treating hyperuricemia in adult gou...
Regulatory Approvals28 Jul 2025
Krystal Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYJUVEK® (beremagene geperpavec-svdt) for treating dystr...
Regulatory Approvals28 Jul 2025
BeOne Medicines announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recomme...
Regulatory Approvals23 Jul 2025
Health Canada has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone, or with pomalidomide and dexamethasone, fo...
Regulatory Approvals22 Jul 2025
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 Approvals16 Jul 2025
ProKidney announced FDA confirmation that the accelerated approval pathway for rilparencel, an autologous cellular therapy for chronic kidney disease ...
Regulatory Approvals16 Jul 2025
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...
Regulatory Approvals15 Jul 2025
Sun Pharma announced the launch of LEQSELVI™ (deuruxolitinib) in the United States for the treatment of adults with severe alopecia areata. LEQSELVI ...
Regulatory Approvals15 Jul 2025
Caranx Medical announced FDA clearance for TAVIPILOT Soft, the world's first AI software for real-time intra-operative guidance of transcatheter aorti...
Regulatory Approvals15 Jul 2025
Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for relacorilant, a selective cortisol modulator, in combinat...
Regulatory Approvals15 Jul 2025
Vertex Pharmaceuticals announced that its non-opioid pain medication, JOURNAVX™ (suzetrigine), has been recognized as a groundbreaking healthcare tech...
Regulatory Approvals14 Jul 2025
The U.S. Food and Drug Administration (FDA) has approved KERENDIA® (finerenone) to treat heart failure (HF) with left ventricular ejection fraction (L...
Regulatory Approvals14 Jul 2025
Zevra Therapeutics announced that MIPLYFFA® (arimoclomol), the first FDA-approved treatment for Niemann-Pick disease type C (NPC), will be featured in...
Regulatory Approvals14 Jul 2025
Valneva announced that the European Medicines Agency (EMA) has lifted the temporary restriction on using its single-dose chikungunya vaccine, IXCHIQ®,...
Regulatory Approvals14 Jul 2025
Ultragenyx's investigational gene therapy, UX111, for Sanfilippo syndrome type A, was rejected by the FDA due to manufacturing concerns. The FDA's co...
Regulatory Approvals14 Jul 2025
Zenith Epigenetics announced that the FDA granted Fast Track designation to ZEN-3694, in combination with abemaciclib, for treating metastatic or unre...
Regulatory Approvals10 Jul 2025
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 Approvals10 Jul 2025
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 Approvals09 Jul 2025
Insightec announced FDA approval of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson's ...
Regulatory Approvals08 Jul 2025
Novartis announced that Coartem® (artemether-lumefantrine) Baby, also known as Riamet® Baby, has received approval from Swissmedic as the first malari...
Regulatory Approvals01 Jul 2025
EmpNia Inc. announced FDA clearance for its eMotus™ system, a disposable sensor pad and software for managing respiratory motion in image-guided radia...
Regulatory Approvals30 Jun 2025
HUTCHMED announced that the China National Medical Products Administration (NMPA) approved the combination of ORPATHYS® (savolitinib) and TAGRISSO® (o...
Regulatory Approvals25 Jun 2025
enGene Holdings Inc. announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational therapy, det...
Regulatory Approvals25 Jun 2025
Syndax Pharmaceuticals announced that the FDA granted Priority Review to its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) to tre...
Regulatory Approvals20 Jun 2025
The FDA has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), a chronic, debilitating, rare skin disease. This ...
Regulatory Approvals20 Jun 2025
Ipsen announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Cabometyx (ca...
Regulatory Approvals20 Jun 2025
Relief Therapeutics announced that its RLF-TD011, a hypochlorous acid solution for epidermolysis bullosa (EB), was not granted Qualified Infectious Di...
