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Pharmaceutical industry news

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馃嚭馃嚢Researchnature.comTier 2 路 Direct publisher

Association between CYP2D6 genotype and treatment effectiveness and safety in 99 hospitalized patients with major depressive disorder a retrospective cohort study CYP2D6 genotype and antidepressant response

The Pharmacogenomics JournalOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Agency Information Collection Activities: Proposed Collection; Comment Request

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Gardenia Blue Interest Group; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

International Association of Color Manufacturers; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food addit...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

GNT USA, LLC.; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Survey on HRSA Customer Service, OMB No. 0906-0084-Revision

In compliance with the requirement for opportunity for public comment on proposed data collection pr...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Professions Student Loan Program, Loans for Disadvantaged Students Program, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements, OMB No. 0906-0088-E

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Req...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Maternity and Obstetrics Management Strategies Program Data Collection, OMB No. 0915-0394-Revision

In compliance with the requirement for opportunity for public comment on proposed data collection pr...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Notice of Award of a Sole Source Cooperative Agreement To Fund Ministry of Health Zambia

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Hu...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryfederalregister.govTier 1 路 Regulatory source

Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Serv...

Federal RegisterOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug label update: unspecified product

Official structured record identifier: 035c5e2a-04e3-490b-8f1a-233a5cb6eadb.

openFDA Drug LabelsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: DIOVAN

Official structured record identifier: 99552.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

Official structured record identifier: 99547.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: CLEAR EYES MAXIMUM ITCHY EYE RELIEF

Official structured record identifier: 99532.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: CLINDAMYCIN PALMITATE HYDROCHLORIDE

Official structured record identifier: 99526.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: OPTIRAY

Official structured record identifier: 99510.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

Official structured record identifier: 99509.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01

Official structured record identifier: 99505.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: CEFAZOLIN

Official structured record identifier: 99463.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Drug recall: Kian Pee Wan Capsules, 30-count bottles

Official structured record identifier: 98650.

openFDA Drug RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Official structured record identifier: 99450.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Official structured record identifier: 99441.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Official structured record identifier: 99433.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

Official structured record identifier: 99432.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Official structured record identifier: 99423.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This s

Official structured record identifier: 99422.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Official structured record identifier: 99407.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

Official structured record identifier: 99405.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GA

Official structured record identifier: 99390.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Cat

Official structured record identifier: 99380.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

Official structured record identifier: 99378.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Official structured record identifier: 99369.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Official structured record identifier: 99343.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

Official structured record identifier: 99341.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Official structured record identifier: 99285.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

Official structured record identifier: 99266.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used t

Official structured record identifier: 99264.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Official structured record identifier: 99261.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a

Official structured record identifier: 99260.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

Official structured record identifier: 99143.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of

Official structured record identifier: 98998.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.

Official structured record identifier: 98909.

openFDA Device RecallsOriginal source
馃嚭馃嚫Regulatoryopen.fda.govTier 1 路 Regulatory source

Device recall: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.

Official structured record identifier: 98777.

openFDA Device RecallsOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Etoricoxib Versus Diclofenac Sodium Intramuscular Injections in Acute Orthopaedic Pain Management: A Randomized, Open-Label Pilot Trial

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Evaluating the Early Adaptation of a Multi-Component Active Case Finding Strategy for Drug-Resistant Tuberculosis in Aden, Yemen: Implementation Science Study

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Transversus Abdominis Plane Block with Liposomal Bupivacaine versus Ropivacaine for Postoperative Cesarean Analgesia: A Randomized Controlled Trial.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Principles and applications of cross-sectional, case-control and cohort studies in gynecologic oncology: from classical observational designs to target trial emulation.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

A randomised, open-label clinical study on the efficacy of baloxavir marboxil and oseltamivir for post-exposure prevention of influenza in a hospital setting: a study protocol.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Antibody-drug conjugate development in lymphoma: a systematic clinical trial landscape analysis.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% as Maintenance Therapy for Japanese Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Multifocal Motor Neuropathy: A Phase 3, Open-label Clinical Trial.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

The Effects of Tildrakizumab in the Epigenetic Aging Deviation of Psoriasis: A 52-Week Open-Label Study.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Non-canonical phage-bacterium interactions during topical phage therapy in the PhagoBurn clinical trial: a retrospective, observational, reverse translational study.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Telisotuzumab adizutecan for metastatic colorectal cancer: a c-MET-targeted antibody-drug conjugate with a topoisomerase inhibitor payload.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Arginine Therapy for Sickle Cell Disease Acute Pain Episodes: The STArT Randomized Clinical Trial.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Effect of alpha-lipoic acid supplementation on polycystic ovary syndrome clinical outcome in infertile females treated with letrozole: a randomized controlled trial.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Fremanezumab for the preventive treatment of migraine in Chinese adults: A Phase 3, randomized controlled trial with an open-label extension.

Europe PMCOriginal source
馃嚜馃嚭Researcheuropepmc.orgTier 2 路 Direct publisher

Lesser-known medication safety considerations in sickle cell disease.

Europe PMCOriginal source
馃實Researchdoi.orgTier 1 路 Research record

Molecular Characterisation of the Diego and Wright Blood Group Systems of Blood Donors in Malta: A PCR-RFLP Study

CrossrefOriginal source
馃實Researchdoi.orgTier 1 路 Research record

Integration of clinical and T-cell immune profiling to predict early response to CD3xBCMA bispecific antibody immunotherapy in Multiple Myeloma

CrossrefOriginal source