Monthly FDA Guidance and Regulatory News Review - December 2025

December 2025 capped the year with a robust slate of FDA activity, including multiple final and draft guidances addressing labeling, safety reporting, clinical trials, and real-world evidence, alongside notable regulatory news and multiple drug and biologic approvals. These developments provide Veristat clients with timely insight into evolving FDA expectations that may influence submissions and regulatory interactions as programs move into 2026. 

FDA Final Guidance:

QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry (published 03-Dec-2025)
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Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (published 09-Dec-2025)
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Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry (published 15-Dec-2025)
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Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry (published 15-Dec-2025)
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Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Guidance for Industry (published 15-Dec-2025)
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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (published 18-Dec-2025)
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Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry (published 19-Dec-2025)
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Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act (published 22-Dec-2025)
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FDA Draft Guidance:

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry (published 02-Dec-2025)
Draft FDA Guidance

Study of Sex Differences in the Clinical Evaluation of Medical Products ((published 02-Dec-2025)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 12/11/2025
Drug Name: ORLADEYONDA #219776
Active Ingredients: BEROTRALSTAT DIHYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: BIOCRYST

Approval Date: 12/11/2025
Drug Name: DAYBUE STIXNDA #219884
Active Ingredients: TROFINETIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ACADIA PHARMS INC

Approval Date: 12/12/2025
Drug Name: CARDAMYSTNDA #218571
Active Ingredients: ETRIPAMIL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: MILESTONE PHARMS USA

Approval Date: 12/12/2025
Drug Name: NUZOLVENCENDA #219491
Active Ingredients: ZOLIFLODACIN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ENTASIS THERAP

Approval Date: 12/12/2025
Drug Name: LEROCHOLBLA #761427
Active Ingredients: LERODALCIBEP-LIGA
Submission Classification*:
Review Priority**:
Company: LIB THERAPEUTICS, INC.

Approval Date: 12/16/2025
Drug Name: VYBRIQUENDA #210858
Active Ingredients: SILDENAFIL CITRATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: IBSA

Approval Date: 12/16/2025
Drug Name: EXDENSURBLA #761458
Active Ingredients: DEPEMOKIMAB-ULAA
Submission Classification*:
Review Priority**:
Company: GLAXOSMITHKLINE LLC

Approval Date: 12/17/2025
Drug Name: RYBREVANT FASPROBLA #761433
Active Ingredients: AMIVANTAMAB AND HYALURONIDASE-LPUJ
Submission Classification*:
Review Priority**:
Company: JANSSEN BIOTECH

Approval Date: 12/18/2025
Drug Name: NUFYMCOBLA #761473
Active Ingredients: RANIBIZUMAB-LEYK
Submission Classification*:
Review Priority**:
Company: FORMYCON AG

Approval Date: 12/19/2025
Drug Name: MYQORZONDA #219083
Active Ingredients: AFICAMTEN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: CYTOKINETICS

Approval Date: 12/19/2025
Drug Name: JASCAYDNDA #220449
Active Ingredients: NERANDOMILAST
Submission Classification*: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
Review Priority**: Priority
Company: BOEHRINGER INGELHEIM

Approval Date: 12/19/2025
Drug Name: BONCRESABLA #761456
Active Ingredients: DENOSUMAB-MOBZ
Submission Classification*:
Review Priority**:
Company: AMNEAL PHARMS LLC

Approval Date: 12/19/2025
Drug Name: OZILTUSBLA #761457
Active Ingredients: DENOSUMAB-MOBZ
Submission Classification*:
Review Priority**:
Company: AMNEAL PHARMS LLC

Approval Date: 12/22/2025
Drug Name: MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMNDA #217338
Active Ingredients: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: RB HLTH

Approval Date: 12/22/2025
Drug Name: WEGOVYNDA #218316
Active Ingredients: SEMAGLUTIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: NOVO

Approval Date: 12/23/2025
Drug Name: YARTEMLEABLA #761152
Active Ingredients: NARSOPLIMAB
Submission Classification*:
Review Priority**:
Company: OMEROS CORP

Approval Date: 12/30/2025
Drug Name: NEREUSNDA #220152
Active Ingredients: TRADIPITANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: VANDA PHARMS INC

Upcoming Advisory Board Meetings

N/A

Commenters seek details on RMAT designation (published 01-Dec-2025)
Read Article on RAPS.org

FDA issues draft guidance to help medical gas manufacturers comply with new tailored GMPs (published 01-Dec-2025)
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EMA considers new biomarkers, patient populations in proposed Parkinson’s disease guideline update (published 02-Dec-2025)
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FDA guidance would cut back on using monkeys for safety testing of monoclonal antibodies (published 02-Dec-2025)
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BsUFA: Industry seeks enhancements for next biosimilars program (published 03-Dec-2025)
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FDA finalizes guidance on biologic, biosimilar promotional labeling (published 09-Dec-2025)
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FDA to tighten approval requirements for CAR T-cell therapies (published 09-Dec-2025)
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CBER official stresses importance of preapproval inspection readiness (published 10-Dec-2025)
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FDA panel calls for easing restrictions on testosterone replacement therapy for men (published 12-Dec-2025)
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ICH looks to revamp its guidelines on cell and gene therapies (published 15-Dec-2025)
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FDA finalizes safety reporting guidances for sponsors and investigators (published 18-Dec-2025)
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FDA loosens restrictions on using patient-level RWD in medical device submissions (published 18-Dec-2025)
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• Article: FDA Delays Push Biotech Companies to Rethink U.S. Drug Development Strategy
• Webinar Presentation: Selecting the Right Oncology CRO Partner
• Blog: Bayesian Study Designs in Early-Phase Oncology Trials

Taylor Mulkerin

Associate Project Manager, Regulatory Affairs

Taylor Mulkerin is an Associate Project Manager of Regulatory Affairs at Veristat. Taylor brings extensive experience supporting regulatory projects across a broad spectrum of therapeutic areas, including rare diseases, infectious diseases, neurology, cardiovascular, diabetes, oncology, atopic dermatitis, gastroenterology, and CNTF.

His expertise spans the full regulatory lifecycle—from preclinical and Phase 1–3 development through to NDA and BLA submissions, approvals, and post-approval activities. Taylor has provided project management support for key regulatory milestones such as Orphan Drug Designation (ODD), pre-IND and IND submissions, Drug Master Files (DMF), and End-of-Phase 2 (EOP2) meetings.

At Veristat, Taylor contributes to the company's impressive track record of supporting 160+ marketing applications and achieving 80+ regulatory approvals, helping sponsors navigate the complexities of drug development and regulatory submission processes.