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Pipeline and approval signals

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

1,114 of 1,114 tracked regulatory updates from 40 agencies and publishers, page 1 of 23.

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

ClinicalTrials.govGlobal1d agoSequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder CancerPhase 3 | NOT_YET_RECRUITING | Assiut University | Sequential Systemic ChemotherapyClinicalTrials.gov ClinicalTrials.govGlobal1d agoRevascularization of Immature Teeth With Our Different ScaffoldsNA | COMPLETED | Tanta UniversityClinicalTrials.gov ClinicalTrials.govGlobal1d agoUpper Body Ischemic Preconditioning and Judo PerformanceNA | COMPLETED | Kastamonu UniversityClinicalTrials.gov ClinicalTrials.govGlobal1d agoLacriFill Canalicular Occlusion for Dry Eye After LASIKNA | NOT_YET_RECRUITING | Mann Eye InstituteClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study Comparing Two Liquid Forms of Cannabidiol (CBD) in Healthy AdultsHuman Pharmacology (Phase I)- Other | Authorised, recruitment pending | Cardiol Therapeutics Inc.ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA clinical trial of MK-1568 in participants with prostate cancer (MK-1568-001)Human Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | Merck Sharp & Dohme LLCClinicalTrials.gov ClinicalTrials.govGlobal1d agoA single-center, randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacokinetics of a single intravenous dose of EuBAT in healthy male and female participants.Human Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | FabentechClinicalTrials.gov ClinicalTrials.govGlobal1d agoThe Swedish study of shortened antibiotic treatment after surgery for Pediatric Acute Perforated Appendicitis; a randomized controlled non-inferiority study (RCT) comparing 3 versus 5 days of postoperative antibiotics.Therapeutic use (Phase IV) | Authorised, recruitment pending | Vaestra Goetalandsregionen | Metronidazol EQL Pharma 400 mg filmdragerade tabletter | Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion | Spektramox 80 mg/ml+12 mg/ml pulver till oral suspensionClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Randomized, Double-Blind, Placebo-Controlled, Multi-centre Study to Evaluate the Pharmacodynamic Effects of Teverelix DP, a GnRH Antagonist, on Prostate Volume and Urinary Function in Men following a First Episode of Acute Urinary Retention (AUR)Therapeutic exploratory (Phase II) | Authorised, recruitment pending | Antev Limited | Teverelix | Teverelix TFAClinicalTrials.gov ClinicalTrials.govGlobal1d agoFirst-in-human trial of an intranasal outer membrane vesicle-based pneumococcal vaccine (Ab-01.12)Human Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | Radboud universitair medisch centrum StichtingClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age with Moderate-to-Severe Atopic DermatitisTherapeutic confirmatory (Phase III) | Authorised, recruitment pending | Nektar Therapeutics | NKTR-358 | Sodium Chloride 0.9% solutionClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age with Moderate-to-Severe Atopic Dermatitis (ZENITH AD-1)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Nektar Therapeutics | NKTR-358 | Sodium Chloride 0.9% solutionClinicalTrials.gov ClinicalTrials.govGlobal1d agoAssessment of self-perceived stress and repetitive behaviors after six weeks of daily intranasal oxytocin administration versus placebo: a randomised, multicentre, parallel group pragmatic trial in 210 men and women with autismTherapeutic confirmatory (Phase III) | Authorised, recruitment pending | UZ Leuven | Placebo - physiological water-based nasal sprays (NaCl 0.9%) | Oxytocin CD Pharma 6 | 7 mikrogram/dos nässprayClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Multicentre, open label, Phase I-Ib Clinical Trial Combining Melanoma-Specific Peptide Vaccination (UniCanVax) and Anti PD-1 Inhibitor (Nivolumab) in Immune Checkpoint Blockade Refractory Metastatic or Unresectable Stage III/IV Melanoma PatientsHuman Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | Humanitas Mirasole S.p.A.ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study of LY4152199 in Participants with Previously Treated B-cell Malignancies (BAF_FRontier-1)Human Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | Eli Lilly & Co.ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults with Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)Therapeutic exploratory (Phase II) | Authorised, recruitment pending | Regeneron Pharmaceuticals Inc. | ALN-CIDEB | Placebo matching ALN-CIDEBClinicalTrials.gov ClinicalTrials.govGlobal1d agoStress, Coping, and Sleep Health StudyN/A | NOT_YET_RECRUITING | National Institute of Environmental Health Sciences (NIEHS)ClinicalTrials.gov ClinicalTrials.govGlobal1d agoStudy to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) CancersPhase 2 | RECRUITING | Genmab | Rina-SClinicalTrials.gov ClinicalTrials.govGlobal1d agoInvestigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy VolunteersPhase 2 | NOT_YET_RECRUITING | National Center for Complementary and Integrative Health (NCCIH) | (2R,6R)-Hydroxynorketamine | PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)Phase 3 | RECRUITING | Generate Biomedicines | GB-0895 | PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d ago[Trial of device that is not approved or cleared by the U.S. FDA]N/A | WITHHELD | [Redacted]ClinicalTrials.gov ClinicalTrials.govGlobal1d agoInternet-Based EMDR Flash Intervention for Test Anxiety in University StudentsNA | RECRUITING | Tokat Gaziosmanpasa UniversityClinicalTrials.gov ClinicalTrials.govGlobal1d agoIntraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical TrialNA | RECRUITING | Aula Dental AvanzadaClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study of JNJ-95437446 in Participants With Advanced-Stage Solid TumorsPhase 1 | RECRUITING | Janssen Research & Development, LLC | JNJ-95437446 | AmivantamabClinicalTrials.gov ClinicalTrials.govGlobal1d agoStudy of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate CancerPhase 1 | RECRUITING | Janssen Research & Development, LLC | JNJ-101556143 Formulation 1 | JNJ-101556143 Formulation 2 | JNJ-101556143 Formulation 3ClinicalTrials.gov ClinicalTrials.govGlobal1d agoMulticenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric PatientsPhase 3 | RECRUITING | Intra-Cellular Therapies, Inc. | Lumateperone high dose | Lumateperone low dose | PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d agoSMART-r: Substance Monitoring and Active Relapse Tracking RepositoryN/A | RECRUITING | National Institute on Drug Abuse (NIDA)ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung CancerPhase 2 | RECRUITING | Janssen Research & Development, LLC | Amivantamab | Lazertinib | CarboplatinClinicalTrials.gov ClinicalTrials.govGlobal1d agoUS Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic CholecystectomyNA | RECRUITING | Assiut UniversityClinicalTrials.gov ClinicalTrials.govGlobal1d agoAtrial Fibrillation Patients Treated With Catheter AblationN/A | RECRUITING | Peking Union Medical College HospitalClinicalTrials.gov ClinicalTrials.govGlobal1d agoMiddle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCANA | COMPLETED | Cerenovus, Part of DePuy Synthes Products, Inc.ClinicalTrials.gov ClinicalTrials.govGlobal1d agoClinical Outcomes of USCTR vs. mOCTRNA | COMPLETED | Walter Reed National Military Medical CenterClinicalTrials.gov ClinicalTrials.govGlobal1d agoIntravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord InjuryPhase 2 | COMPLETED | Medstar Health Research Institute | Culturelle 10 Billion CFU Capsule (2 doses) | Culturelle 10 Billion CFU Capsule (4 doses)ClinicalTrials.gov ClinicalTrials.govGlobal1d agoMR Imaging Study Using the Northern Alberta Linac-MR (Northern LIGHTs - 1)NA | RECRUITING | AHS Cancer Control AlbertaClinicalTrials.gov ClinicalTrials.govGlobal1d agoItacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell TransplantationPhase 2 | COMPLETED | City of Hope Medical Center | Fludarabine | Itacitinib Adipate | MelphalanClinicalTrials.gov ClinicalTrials.govGlobal1d agoPembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.Phase 1 | ACTIVE_NOT_RECRUITING | City of Hope Medical Center | Pembrolizumab | VorinostatClinicalTrials.gov ClinicalTrials.govGlobal1d agoGenetics of Type 2 Diabetes in West AfricansN/A | RECRUITING | National Human Genome Research Institute (NHGRI)ClinicalTrials.gov ClinicalTrials.govGlobal2d agoBRAF AND BCL-2 CO-INHIBITION WITH VEMURAFENIB AND VENETOCLAX AS A RATIONAL, SHORT, ALL-ORAL TARGETED THERAPY, FOLLOWED BY MRD-GUIDED ANTI-CD20 IMMUNOTHERAPY WITH RITUXIMAB, IN RELAPSED/REFRACTORY HAIRY CELL LEUKEMIA: A SINGLE-CENTER PHASE-2 TRIAL (HCL-PG06)Therapeutic exploratory (Phase II) | Not authorised | Azienda Ospedaliera Di Perugia, Universita Degli Studi Di Perugia | Rixathon 500 mg concentrate for solution for infusion | Venclyxto 100 mg film-coated tablets | Zelboraf 240 mg film-coated tabletsClinicalTrials.gov ClinicalTrials.govGlobal2d agoPHASE II RANDOMISED CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PAPAVERINE IN PREVENTING ARTERIAL VASOSPASM AND REDUCING POSTOPERATIVE HYPOPARATHYROIDISM IN ADULT PATIENTS UNDERGOING TOTAL THYROIDECTOMY – PPPTH trialTherapeutic exploratory (Phase II) | Authorised, recruitment pending | Azienda Provinciale Per I Servizi Sanitari | PAPAVERINE | SALINEClinicalTrials.gov ClinicalTrials.govGlobal2d agoStudy to Evaluate the Effect of a Single Oral Dose of Zoliflodacin on Testicular Function in Healthy Adult MenHuman Pharmacology (Phase I)- Other | Authorised, recruitment pending | GARDP FoundationClinicalTrials.gov 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 28PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM | ANDA | AP | KNACKFDA 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