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PharmaRadar360

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Pharmaceutical industry news

Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.

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🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Natures Willow Balm Pain Relief XL Patch

Official structured record identifier: 0ce13ead-fc34-b1e6-e063-6394a90a3d67.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Aller-chlor

Official structured record identifier: 04ca3806-72be-47d4-9fea-5b0dee087683.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: topiramate

Official structured record identifier: 0366164b-1846-443d-9564-dbe52d8d9b65.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: Paroxetine

Official structured record identifier: 009d8b89-eab9-43ba-b077-86bfa993a745.

openFDA Drug LabelsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: CINACALCET

Official structured record identifier: 99350.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.

Official structured record identifier: 99319.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: GLUCAGON

Official structured record identifier: 99296.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45

Official structured record identifier: 99233.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: CHLORAPREP ONE-STEP

Official structured record identifier: 99217.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: IMULDOSA

Official structured record identifier: 99216.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: ACCUCAINE

Official structured record identifier: 99204.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: LEVOTHYROXINE SODIUM

Official structured record identifier: 99194.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug recall: PREDNISOLONE ACETATE

Official structured record identifier: 99144.

openFDA Drug RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Official structured record identifier: 99239.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: ARTIS icono ceiling. Model Number: 11328100.

Official structured record identifier: 99224.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

Official structured record identifier: 99209.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHES

Official structured record identifier: 99162.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: RayCare 2024A SP1. Oncology Information Systems.

Official structured record identifier: 99141.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806

Official structured record identifier: 99140.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Official structured record identifier: 99132.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device

Official structured record identifier: 99119.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A

Official structured record identifier: 99100.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated f

Official structured record identifier: 99096.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: CRE Pro Wireguided 12-15mm 240cm

Official structured record identifier: 99067.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).

Official structured record identifier: 99034.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Official structured record identifier: 99028.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston

Official structured record identifier: 98981.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Descrip

Official structured record identifier: 98962.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 1

Official structured record identifier: 98819.

openFDA Device RecallsOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Device recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695

Official structured record identifier: 98481.

openFDA Device RecallsOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Comparison of the Efficacy of Ciprofol and Propofol for Rapid Sequence Induction and Intubation in Elective Non-Cardiac Surgery: A Prospective, Randomized, Non-Inferiority Trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Polatuzumab Vedotin Enhances Intratumoral T-Cell Infiltration and Demonstrates Combinatorial Efficacy With Anti-CD20/CD3 Bispecific Antibody in a Syngeneic B-Cell Malignancy Mouse Model.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Effectiveness of cefazolin versus anti-staphylococcal β-lactam for treating methicillin-susceptible Staphylococcus aureus pneumonia in critically ill patients admitted to intensive care units: a multicenter cohort study.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Joint impact of the number of comorbidities and the COVID-19 pandemic on the concordance of antibiotic prescriptions with clinical guidelines, in the community.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Efficacy and safety of eribulin mesylate vs. docetaxel or paclitaxel, combined with trastuzumab and pertuzumab, as first-line treatment for HER2-positive locally advanced or metastatic breast cancer: updated subgroup analyses of JBCRG-M06/EMERALD.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Safety and early efficacy of iPSC-derived motor neuron progenitor cells in subacute spinal cord injury: protocol for a phase I, multicentre, open-label, single-arm trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Trial paper is retracted as FDA keeps scrutiny on controversial vasculitis drug.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Emergency department longitudinal integrated care (EDLINC) study: Protocol for a pragmatic effectiveness randomized clinical trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Latent Class Analysis to Identify Phenotype-Specific Treatment Effects of Catheter Ablation Versus Drug Therapy in Patients with Atrial Fibrillation: A Secondary Analysis of the CABANA Trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Efficacy and safety of rivaroxaban, colchicine, and famotidine-loratadine with specialist supportive clinical care for fatigue in patients with post-COVID-19 condition in the UK: a multisite, open-label, randomised controlled trial.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Phase I first-in-human dose-escalation trial of a bladder cancer-specific nanoparticle in non-muscle-invasive bladder cancer.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Beta-Blockers Versus Flecainide for Atrial Fibrillation: A First-Line Strategy Review of Efficacy, Safety, and Patient Selection.

Europe PMCOriginal source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

Total Clinical Event Burden With Edoxaban Monotherapy Versus Dual Antithrombotic Therapy in Atrial Fibrillation and Stable Coronary Artery Disease: Insights From the EPIC-CAD Trial.

Europe PMCOriginal source
🌍Researchdoi.orgTier 1 · Research record

Aripiprazole versus Bupropion Augmentation in Patients with Anxious Depression Resistant to Selective Serotonin Reuptake Inhibitors: A Randomized, Prospective, Open-label, Multicenter Study

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Reviewer #2 (Public review): Single-cell transcriptome-wide Mendelian randomization and colocalization analyses reveal immune-cell-specific mechanisms and actionable drug targets in prostate cancer

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Single-cell transcriptome-wide Mendelian randomization and colocalization analyses reveal immune-cell-specific mechanisms and actionable drug targets in prostate cancer

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Análise clínica e epidemiológica de pacientes oncológicos em instituição privada em Maceió- AL

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

CBD and Passion Flower for Anxiety: Clinical Use Considerations

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Diversity of Endophytic Fungi Associated with the Aerial Roots of Ficus benghalensis L. in the Sacred Groves of Ponnamaravathi, Pudukkottai District, Tamil Nadu, India

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Hyaluronidase in Aesthetic Plastic Surgery: Clinical Uses, Safety, Ultrasound Guidance, And Current Controversies

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Rothmund-Thomson Syndrome Revisited: Expanding the Genotypic Spectrum, Deciphering RECQL4-Related Pathomechanisms, And Redefining Long-Term Surveillance Strategies for An Underrecognized Genodermatosis

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Epigenetic Regulation in Acute Myeloid Leukemia: Molecular Mechanisms and Clinical Implications

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Case Report: When access is limited: using CYP3A4 inhibition to maintain clinical benefit from elexacaftor/tezacaftor/ivacaftor

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Case Report: From misdiagnosis to successful treatment using mepolizumab in ANCA-negative severe EGPA—clinical lessons in eosinophil-targeted therapy

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Clinical and immunological characterization of NFKB1 haploinsufficiency in Japan

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Clinical characteristics and risk factors of atrial fibrillation detection after acute ischemic stroke

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Divergence in surface protein exposure between reference and clinical-derived Candida glabrata (Nakaseomyces glabratus) strains (CBS138 vs. BG2) – a preliminary proteomic perspective

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Effects of Breaking Up Prolonged Sitting with an Office-Based Exercise Program on Sitting Time, Physical Activity, Musculoskeletal Discomfort, and Stress in Office Workers: A Randomized Controlled Trial

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

The gut microbiome–tumor microenvironment axis in immunotherapy response: Mechanistic insights and clinical implications

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

TO STUDY TEN-YEAR SURVIVAL FOR PATIENTS UNDERGOING CORONARY ENDARTERECTOMY IN PATIENTS WITH CORONARY ARTERY DISEASE

CrossrefOriginal source