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Pharmaceutical industry news

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🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Center for Scientific Review; Notice of Closed Meetings

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information

The Office of the Assistant Secretary for Health (OASH or we) is opening a public docket to solicit...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Patient Safety Organizations: Voluntary Relinquishment for the Cassatt Patient Safety Organization

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on beha...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Po

This proposed rule would set forth routine updates to the Medicare home health payment rates in acco...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Expedited Investigational New Drug Pilot Program; Request for Information; Correction

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Proposed Collection; 60-day Comment Request; Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of the Director)

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Privacy Act of 1974; Matching Program

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Heal...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce pub...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Agency Forms Undergoing Paperwork Reduction Act Review

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...

Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.govTier 1 · Regulatory source

Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that VASOPRESSIN IN SODIUM CHLORIDE...

Federal RegisterOriginal source
🇺🇸Regulatoryopen.fda.govTier 1 · Regulatory source

Drug label update: RIVAROXABAN

Official structured record identifier: 481b7802-5093-43e7-bbd9-1532197eb6e6.

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

Drug label update: Calmco Allergy Relief

Official structured record identifier: 471b1a43-1708-8be7-e063-6394a90a9bb7.

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

Drug label update: Duloxetine

Official structured record identifier: 461d769c-b787-4bc7-b4a6-7a5f33ae9d45.

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

Drug label update: Ibuprofen

Official structured record identifier: 421156d2-85dc-4680-b2b4-d15b67539e87.

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

Drug label update: Deflazacort

Official structured record identifier: 40818600-3ff0-4c9c-8e31-2001425a7dc9.

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

Drug label update: Prazosin Hydrochloride

Official structured record identifier: 39e3fa5d-ea48-4b02-80f6-44591f5e013f.

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

Drug label update: Lisinopril

Official structured record identifier: 34953f77-bae1-41fe-af11-3ea0b3ceaa11.

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

Drug label update: Carvedilol

Official structured record identifier: 32098c09-7580-4975-a3e1-31b619c04c69.

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

Drug label update: Sucralfate

Official structured record identifier: 30c0965a-02a0-46b5-aa09-3f5fb5047b22.

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

Drug label update: Dr Kids Pain and Fever

Official structured record identifier: 2ee6df99-727a-34c6-e063-6294a90a6bbc.

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

Drug label update: Estradiol valerate

Official structured record identifier: 2e5c7559-7420-168d-6272-92bb4d20035d.

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

Drug label update: Methimazole

Official structured record identifier: 2c6a9c70-4ed6-4f05-bc3d-e8e7aca57c2b.

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

Drug label update: Dr Kids Allergy Relief

Official structured record identifier: 28ec213e-fabb-28ec-e063-6394a90ad102.

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

Drug label update: Paroxetine

Official structured record identifier: 28ddc9e0-05c5-482f-9371-60bbee451b33.

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

Drug label update: Levetiracetam

Official structured record identifier: 266d4ead-fda2-f030-e063-6394a90a68e2.

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

Drug label update: Aspirin

Official structured record identifier: 227cefca-acc4-41d0-e063-6394a90a35b9.

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

Drug label update: HGH Plus

Official structured record identifier: 20542ed4-eece-437c-a88f-ccd666afce03.

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

Drug label update: Sunscreen SPF 50

Official structured record identifier: 1d4be26a-4695-491c-85d1-86824e1cd029.

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

Drug label update: Ezetimibe

Official structured record identifier: 090776cf-f211-49a3-a993-ff5d707311f2.

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

Drug label update: Lithium Carbonate

Official structured record identifier: 05312159-3d8a-45e0-99cb-b83a7b200cd3.

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

Drug label update: Hand Sanitizing Wipes

Official structured record identifier: 044361fe-1e16-4fea-9094-a2d88c890d9c.

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

Drug label update: Imipramine Hydrochloride

Official structured record identifier: 02c19a0a-3d9d-4881-ad14-1687aafd87b5.

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

Drug label update: Rapidol Aspirin

Official structured record identifier: 00d9ab0d-ff25-784f-e063-6294a90a8497.

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

Drug label update: ropinirole

Official structured record identifier: 0030ffac-183a-472c-95b8-f93b4195de04.

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

Drug label update: ENTRESTO

Official structured record identifier: 000dc81d-ab91-450c-8eae-8eb74e72296f.

openFDA Drug LabelsOriginal source
🇨🇦Industryir.bauschhealth.comTier 1 · Company source

Le Québec est la première province à inscrire Pr OKEDI MD (suspension injectable à libération prolongée de rispéridone) sur la liste des médicaments remboursés par le régime public pour le traitement de la schizophrénie

Bausch Health (IR News)Original source
🇨🇦Industryir.bauschhealth.comTier 1 · Company source

Québec is the first province to list Pr OKEDI MC (extended-release injectable suspension of risperidone) on the public drug reimbursement formulary for the treatment of schizophrenia

Bausch Health (IR News)Original source
🇪🇺Researcheuropepmc.orgTier 2 · Direct publisher

A precision medicine trial of bupropion and sertraline for major depressive disorder using a biomarker-guided sequential multiple-assignment design.

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

Renoprotective Mechanisms of SGLT2 Inhibitors: Integrating Clinical and Experimental Evidence from Inflammation to Fibrosis.

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

Phase II Trial of Nivolumab in Advanced Solid Tumors Based on Genomic Profiling: BELIEVE Trial (NCCH1901) Subcohort.

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

Baseline peak VO₂ and treatment effect consistency of perioperative rehabilitation in cardiac valve surgery: an exploratory subgroup analysis of the PORT trial.

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

Cardiovascular Drug Access in Australia and New Zealand: New PBS and PHARMAC Listings, 2023-2025.

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

Interchangeability of blood culture bottles and automats for blood culture systems: an in-vitro performance evaluation.

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

Macrophage autophagy in allergic diseases: Regulatory mechanisms, immune crosstalk, and therapeutic implications.

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

Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial.

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

Safety and feasibility of 5T4 antibody-coupled allogeneic NK cell therapy for solid tumors: a first-in-human phase 1 trial.

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

Characterizing children with chronic kidney disease and severe proteinuria in the United States: a retrospective analysis using electronic health records.

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

The use of pharmacodynamic results for recommended phase II decision making in oncology clinical trials.

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

Semaglutide Injection Once-Weekly for Weight Management in Adults: Results From A Randomized Phase III, Active-Controlled Study.

Europe PMCOriginal source
🌍Researchdoi.orgTier 1 · Research record

Oropharyngeal dysphagia and gastroesophageal reflux disease in lung transplant patients: a systematic review and meta-analysis of incidence, risk factors, and clinical outcomes

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

ABC will trial using AI for journalism. What are the risks and benefits?

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Peer Review Report For: The Institutional Black Box of Friction Between Digital Agility Demands and Clinical Bureaucracy in Hospital Social Media Management [version 2; peer review: 2 approved]

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Choline PET/CT in the PSMA Era: Clinical Repositioning, Biological Perspectives, and Emerging Applications

CrossrefOriginal source
🌍Researchdoi.orgTier 1 · Research record

Clinical efficacy of STMIPO in the management of distal one-third fibular fractures

CrossrefOriginal source