Monthly FDA Guidance and Regulatory News Review - June 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:

Conducting Remote Regulatory Assessments Questions and Answers (published 24-Jun-2025)
Download FDA Guidance

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (published 26-Jun-2025)
Download FDA Guidance

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (published 26-Jun-2025)
Download FDA Guidance

FDA Draft Guidance:

M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP) (published 06-Jun-2025)
Draft FDA Guidance

Q1 Stability Testing of Drug Substances and Drug Products (published 23-Jun-2025)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 06/05/2025
Drug Name: XIFYRMNDA #218395
Active Ingredients: MELOXICAM
Submission Classification*:
Review Priority**: Standard
Company: AZURITY

Approval Date: 06/05/2025
Drug Name: WIDAPLIKNDA #219423
Active Ingredients: AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: GEORGE MEDICINES

Approval Date: 06/09/2025
Drug Name: ROCURONIUM BROMIDENDA #217472
Active Ingredients: ROCURONIUM BROMIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FRESENIUS KABI USA

Approval Date: 06/09/2025
Drug Name: ENFLONSIABLA #761432
Active Ingredients: CLESROVIMAB-CFOR
Submission Classification*:
Review Priority**:
Company: MERCK SHARP DOHME

Approval Date: 06/10/2025
Drug Name: BRUKINSANDA #218785
Active Ingredients: ZANUBRUTINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: BEONE MEDICINES USA

Approval Date: 06/11/2025
Drug Name: IBTROZINDA #219713
Active Ingredients: TALETRECTINIB ADIPATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: NUVATION

Approval Date: 06/12/2025
Drug Name: ZUSDURINDA #215793
Active Ingredients: MITOMYCIN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: UROGEN PHARMA

Approval Date: 06/16/2025
Drug Name: ARYNTANDA #219847
Active Ingredients: LISDEXAMFETAMINE DIMESYLATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY

Approval Date: 06/16/2025
Drug Name: CARBON DIOXIDE, USPNDA #220634
Active Ingredients: CARBON DIOXIDE
Submission Classification*:
Review Priority**: Unknown
Company: GENERAL DISTRIBUTING COMPANY

Approval Date: 06/16/2025
Drug Name: ANDEMBRYBLA #761367
Active Ingredients: GARADACIMAB-GXII
Submission Classification*:
Review Priority**:
Company: CSL BEHRING LLC

Approval Date: 06/18/2025
Drug Name: YEZTUGONDA #220018
Active Ingredients: LENACAPAVIR
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Priority
Company: GILEAD SCIENCES INC

Approval Date: 06/18/2025
Drug Name: YEZTUGONDA #220018
Active Ingredients: LENACAPAVIR SODIUM
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Priority
Company: GILEAD SCIENCES INC

Approval Date: 06/18/2025
Drug Name: YEZTUGONDA #220020
Active Ingredients: LENACAPAVIR SODIUM
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Priority
Company: GILEAD SCIENCES INC

Approval Date: 06/23/2025
Drug Name: DATROWAYBLA #761464
Active Ingredients: DATOPOTAMAB DERUXTECAN-DLNK
Submission Classification*:
Review Priority**:
Company: DAIICHI SANKYO INC

Approval Date: 06/27/2025
Drug Name: AVGEMSINDA #219920
Active Ingredients: GEMCITABINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AVYXA HOLDINGS

Upcoming Advisory Board Meetings

07/09/2025 Pediatric Advisory Committee Meeting- 10:00 AM EDT to 04:00 PM EDT

07/17/2025 Oncologic Drugs Advisory Committee- 08:00 AM EDT to 12:45 PM EDT

07/18/2025 Psychopharmacologic Drugs Advisory Committee Meeting- 09:00 AM EDT- 04:00 PM EDT

FDA: Majority of applicants complied with postmarketing requirements, commitments (published 02-Jun-2025)
Read Article on RAPS.org

FDA launches agency-wide AI tool ‘Elsa’ ahead of schedule (published 02-Jun-2025)
Read Article on RAPS.org

FDA should establish a public database of device labels, experts say (published 03-Jun-2025)
Read Article on RAPS.org

FDA’s Elsa AI tool gets mixed response from some staff (published 04-Jun-2025)
Read Article on RAPS.org

FDA’s warning letters cite firms over inadequate testing, BIMO violations (published 06-Jun-2025)
Read Article on RAPS.org

FDA issues guidance on transferring 510(k) ownership (published 09-Jun-2025)
Read Article on RAPS.org

Stakeholders urge FDA to update CGT regulations to ease path to market for promising therapies (published 09-Jun-2025)
Read Article on RAPS.org

Makary, Prasad lay out priorities for FDA: Reduced timelines, more AI, faster competition (published 10-Jun-2025)
Read Article on RAPS.org

EMA: Record number of drugs recommended in 2024 (published 10-Jun-2025)
Read Article on RAPS.org

MHRA releases spate of new guidelines on decentralized manufacturing (published 10-Jun-2025)
Read Article on RAPS.org

FDA warns Sprout over Addyi Instagram post, clinical trial sponsor for lacking an IND (published 11-Jun-2025)
Read Article on RAPS.org

Makary: FDA to look into further consolidating operations (published 12-Jun-2025)
Read Article on RAPS.org

Industry tells Congress incentives needed to boost domestic drug manufacturing (published 12-Jun-2025)
Read Article on RAPS.org

Study notes disparities in new drugs approved in the US and Japan (published 13-Jun-2025)
Read Article on RAPS.org

Makary names Prasad as FDA’s chief medical and scientific officer (published 18-Jun-2025)
Read Article on RAPS.org

FDA: If used for document libraries, Elsa cannot hallucinate; unlikely to be connected to the Internet (published 20-Jun-2025)
Read Article on RAPS.org

Corrigan-Curay announces retirement from CDER (published 23-Jun-2025)
Read Article on RAPS.org

FDA, NIH create common vocabulary for real-world evidence (published 23-Jun-2025)
Read Article on RAPS.org

FDA finalizes guidance on requesting post-warning letter meetings (published 23-Jun-2025)
Read Article on RAPS.org

FDA’s LDT oversight faces an uncertain future, experts say (published 24-Jun-2025)
Read Article on RAPS.org

FDA extends deadline for nitrosamine testing submissions (published 24-Jun-2025)
Read Article on RAPS.org

FDA finalizes early Lyme disease drug development guidance (published 25-Jun-2025)
Read Article on RAPS.org

ICH releases E20 guideline to assist sponsors in designing adaptive clinical trials (published 27-Jun-2025)
Read Article on RAPS.org

Study: Some breakthrough-designated devices have limited evidence supporting safety, effectiveness (published 30-Jun-2025)
Read Article on RAPS.org

FDA eliminates REMS for approved CAR-T therapies (published 30-Jun-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.