Monthly FDA Guidance and Regulatory News Review - August 2025

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. 

FDA Final Guidance:

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (published 18-Aug-2025)
Download FDA Guidance

Withdrawn Guidances (Biologics) (published 27-Aug-2025)
Download FDA Guidance

FDA Draft Guidance:

Approaches to Assessment of Overall Survival in Oncology Clinical Trials (published 18-Aug-2025)
Draft FDA Guidance

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development (published 19-Aug-2025)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 08/01/2025
Drug Name: E-Z-DISKNDA #219840
Active Ingredients: BARIUM SULFATE
Submission Classification*: Type 7 - Drug Already Marketed without Approved NDA
Review Priority**: Standard
Company: BRACCO

Approval Date: 08/06/2025
Drug Name: MODEYSONDA #219876
Active Ingredients: DORDAVIPRONE HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: CHIMERIX

Approval Date: 08/08/2025
Drug Name: HERNEXEOSNDA #219042
Active Ingredients: ZONGERTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BOEHRINGER INGELHEIM

Approval Date: 08/08/2025
Drug Name: KYXATANDA #219921
Active Ingredients: CARBOPLATIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AVYXA HOLDINGS

Approval Date: 08/12/2025
Drug Name: BRINSUPRINDA #217673
Active Ingredients: BRENSOCATIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: INSMED INC

Approval Date: 08/15/2025
Drug Name: CYKLXNDA #218643
Active Ingredients: ARTICAINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form and Type 4 - New Combination
Review Priority**: Standard
Company: AM GENOMICS

Approval Date: 08/15/2025
Drug Name: TONMYANDA #219428
Active Ingredients: CYCLOBENZAPRINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: TONIX

Approval Date: 08/21/2025
Drug Name: DAWNZERA (AUTOINJECTOR)NDA #219407
Active Ingredients: DONIDALORSEN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: IONIS PHARMS INC

Approval Date: 08/25/2025
Drug Name: CAMCEVI ETMNDA #219745
Active Ingredients: LEUPROLIDE MESYLATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FORESEE PHARMS

Approval Date: 08/28/2025
Drug Name: LOPRESSORNDA #218698
Active Ingredients: METOPROLOL TARTRATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: XTM CONSULTING

Approval Date: 08/29/2025
Drug Name: OTEZLANDA #210745
Active Ingredients: APREMILAST
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMGEN INC

Approval Date: 08/29/2025
Drug Name: OTEZLA XRNDA #210745
Active Ingredients: APREMILAST
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMGEN INC

Approval Date: 08/29/2025
Drug Name: ESCITALOPRAMNDA #219130
Active Ingredients: ESCITALOPRAM OXALATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ALMATICA

Approval Date: 08/29/2025
Drug Name: WAYRILZNDA #219685
Active Ingredients: RILZABRUTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: GENZYME CORP

Approval Date: 08/29/2025
Drug Name: LEQEMBI IQLIKBLA #761375
Active Ingredients: LECANEMAB-IRMB
Submission Classification*:
Review Priority**:
Company: EISAI INC

Approval Date: 08/29/2025
Drug Name: BILDYOSBLA #761444
Active Ingredients: DENOSUMAB-NXXP
Submission Classification*:
Review Priority**:
Company: SHANGHAI HENLIUS BIOTECH

Approval Date: 08/29/2025
Drug Name: BILPREVDABLA #761444
Active Ingredients: DENOSUMAB-NXXP
Submission Classification*:
Review Priority**:
Company: SHANGHAI HENLIUS BIOTECH

Upcoming Advisory Board Meetings

N/A

Pharma groups suggest changes to FDA’s guidance on replacing color additives (published 04-Aug-2025)
Read Article on RAPS.org

MDUFA VI: FDA eyes growth while industry seeks refinement (published 04-Aug-2025)
Read Article on RAPS.org

FDA issues warning letters for CGMP violations, marketing devices for unintended uses (published 05-Aug-2025)
Read Article on RAPS.org

Industry asks for clarification, consistency in FDA’s 510(k) transfer guidance (published 06-Aug-2025)
Read Article on RAPS.org

EMA proposes updating guideline for Alzheimer's disease treatments (published 06-Aug-2025)
Read Article on RAPS.org

European Commission: Lack of alternatives to TiO2 precludes ban in drugs (published 07-Aug-2025)
Read Article on RAPS.org

ICH releases Q3E guideline on controlling extractables and leachables in drugs (published 07-Aug-2025)
Read Article on RAPS.org

Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling (published 11-Aug-2025)
Read Article on RAPS.org

FDA’s drug quality report notes ‘significant’ uptick in inspections since pandemic (published 11-Aug-2025)
Read Article on RAPS.org

FDA warns Spectra Therapy for GMP violations, marketing unapproved device (published 12-Aug-2025)
Read Article on RAPS.org

FDA seeks feedback on ways to bring manufacturing back to the US (published 15-Aug-2025)
Read Article on RAPS.org

FDA proposes guidance on using overall survival endpoints in cancer drug trials (published 18-Aug-2025)
Read Article on RAPS.org

Majority of pharmaceutical plants located in disaster-prone areas, study shows (published 22-Aug-2025)
Read Article on RAPS.org

Expert recommends alternative approaches to substitute for randomized trials for COVID vaccines (published 25-Aug-2025)
Read Article on RAPS.org

FDA finalizes guidance on using animal studies to develop dental bone grafting devices (published 25-Aug-2025)
Read Article on RAPS.org

FDA’s CDER announces updated guidance agenda for 2025 (published 25-Aug-2025)
Read Article on RAPS.org

Industry wants clarity on scope of ICH stability testing guideline, timing of studies (published 26-Aug-2025)
Read Article on RAPS.org

FDA warns companies for GLP, CGMP, and marketing violations (published 26-Aug-2025)
Read Article on RAPS.org

FDA approves updated COVID vaccines with restrictions on their use (published 27-Aug-2025)
Read Article on RAPS.org

FDA officials explain how to ensure registries generate fit-for-purpose data (published 28-Aug-2025)
Read Article on RAPS.org

Experts call for more guidance from FDA on registries in oncology (published 29-Aug-2025)
Read Article on RAPS.org

• 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.