PharmaRadar360

Entity and regulatory intelligence

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Pipeline and approval signals

Search agency notices, approvals, recalls, and regulatory updates from global authorities.

89 of 1,114 tracked regulatory updates from 40 agencies and publishers, page 1 of 2.

All 1,114 FDA 89 EMA 7 MHRA 60 PMDA 31 DHSC 60 Health Canada 60 UKHSA 60 MFDS 60

FDAUnited States5d agoMINIVELLEESTRADIOL | NDA | AP | NOVENFDA FDAUnited States5d agoVIVELLEESTRADIOL | NDA | AP | SANDOZFDA FDAUnited States5d agoESTRADIOLESTRADIOL | NDA | AP | SANDOZFDA FDAUnited States6d agoILUMYATILDRAKIZUMAB-ASMN | BLA | AP | SUN PHARMA GLOBALFDA FDAUnited States6d agoCISPLATINCISPLATIN | NDA | AP | AVYXA HOLDINGS, LLC.FDA FDAUnited StatesOct 28VENETOCLAXVENETOCLAX | ANDA | AP | ALEMBICFDA FDAUnited StatesOct 28PIQRAYALPELISIB | NDA | AP | NOVARTISFDA FDAUnited StatesOct 28OLANZAPINE AND SAMIDORPHANOLANZAPINE, SAMIDORPHAN | ANDA | TA | TEVA PHARMACEUTICALS INCFDA FDAUnited StatesOct 28IFEX/MESNEX KITIFOSFAMIDE | NDA | AP | BAXTER HLTHCAREFDA FDAUnited StatesOct 28KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDE | ANDA | AP | NEURORXFDA FDAUnited StatesOct 28TRIAMTERENETRIAMTERENE | ANDA | AP | RUBICON RESEARCHFDA FDAUnited StatesOct 28FULVESTRANTFULVESTRANT | ANDA | AP | SINOPEP ALLSINOFDA FDAUnited StatesOct 28PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM | ANDA | AP | KNACKFDA FDAUnited StatesOct 27BOSENTANBOSENTAN | ANDA | AP | AMNEAL PHARMS COFDA FDAUnited StatesOct 27TRACLEERBOSENTAN | NDA | AP | ACTELIONFDA FDAUnited StatesOct 27BOSENTANBOSENTAN | ANDA | AP | NATCO PHARMA LTDFDA FDAUnited StatesOct 27VORICONAZOLEVORICONAZOLE | ANDA | AP | SANDOZ INCFDA FDAUnited StatesOct 27YORVIPATHPALOPEGTERIPARATIDE | NDA | AP | ASCENDIS PHARMA BONEFDA FDAUnited StatesOct 27LYTGOBIFUTIBATINIB | NDA | AP | TAIHO ONCOLOGYFDA FDAUnited StatesOct 27CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE | ANDA | AP | NATCO PHARMA LTDFDA FDAUnited StatesOct 27RANIBIZUMABRANIBIZUMAB | BLA | AP | XBRANE BIOPHARMA ABFDA FDAUnited StatesOct 27RIVAROXABANRIVAROXABAN | ANDA | AP | TEVA PHARMS USAFDA FDAUnited StatesOct 27FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE | ANDA | AP | L PERRIGO COFDA FDAUnited StatesOct 27BOSENTANBOSENTAN | ANDA | AP | ZYDUS PHARMSFDA FDAUnited StatesOct 27BOSENTANBOSENTAN | ANDA | AP | NATCO PHARMA LTDFDA FDAUnited StatesOct 27BOSENTANBOSENTAN | ANDA | AP | ZYDUS PHARMSFDA FDAUnited StatesOct 27TRACLEERBOSENTAN | NDA | AP | ACTELIONFDA FDAUnited StatesOct 27NARATRIPTANNARATRIPTAN HYDROCHLORIDE | ANDA | AP | ORBION PHARMSFDA FDAUnited StatesOct 27TRANEXAMIC ACIDTRANEXAMIC ACID | ANDA | AP | ZYDUS LIFESCIENCESFDA FDAUnited States1d agoWithdrawn and Expired Guidances | DrugsFDA Drug Safety Communications FDAUnited States2d agoFDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked BarsFDA MedWatch FDAUnited States2d agoEarly Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+FDA MedWatch FDAUnited States4d agoMenopausal Hormone Therapies with Updated Prescribing InformationFDA Drug Safety Communications FDAUnited States5d agoPlatelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)FDA MedWatch FDAUnited States5d agoHospital Glucose Meter Correction: Nova Biomedical Updates Use Instructions for StatStrip Glucose Hospital Meter SystemsFDA MedWatch FDAUnited States5d agoDrug label update: ProsaceaopenFDA Drug Labels FDAUnited States5d agoDrug label update: Fungicure Anti-Fungal WashopenFDA Drug Labels FDAUnited States6d agoEarly Alert: Medline Removes or Corrects All Medline Brand Beds and AccessoriesFDA MedWatch FDAUnited StatesOct 28Drug recall: LEVOXYLopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6openFDA Drug Recalls FDAUnited StatesOct 28Drug recall: Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office Use Only, 8400 Esters Blvd, STE 190, Irving, TX 75063.openFDA Drug Recalls FDAUnited StatesOct 28Drug recall: CINACALCETopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: ARGATROBANopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: AMITRIPTYLINE HYDROCHLORIDEopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: AMLODIPINE AND OLMESARTAN MEDOXOMILopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: HEPARIN SODIUMopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: TELMISARTAN AND AMLODIPINEopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: ABIRTEGAopenFDA Drug Recalls FDAUnited StatesOct 28Drug recall: Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.openFDA Drug Recalls FDAUnited StatesOct 28Device recall: MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.openFDA Device Recalls