Pharmaceutical industry news
Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.
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Otsuka Presents Landmark Final Phase 3 VISIONARY Results at ASN Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilized Kidney Function and Reduced Risk of Disease Progression and Kidney Failure, Redefining Treatment Paradigm in IgA Nephropathy
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...
Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO
The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of...
Proposed Information Collection Activity; Child Care and Development Fund Plan Preprint for States/Territories for Federal Fiscal Year (FFY) 2028-2030 (ACF-118) and extension of Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025-2027
The Administration for Children and Families (ACF) is requesting an extension without changes of the...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: Advanced Nursing Education Program Specific Form OMB No. 0906-0089-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Req...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0906-0081-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Req...
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft...
Request for Public Comment: 60-Day Notice for Reinstated Collection: Division of Urban Indian Affairs Uniform Data System and Budget Formulation
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the...






