Monthly FDA Guidance and Regulatory News Review - February 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:

Institutional Review Board (IRB) Written Procedures (published 05-Feb-2025)
Download FDA Guidance

Monthly FDA Approvals

Approval Date: 02/02/2025
Drug Name: Carbon Dioxide, USPNDA #220266
Active Ingredients: Carbon Dioxide
Submission Classification*: Medical Gas
Review Priority**: Unknown
Company: WELDERS SUPPLY COMPANY OF LOUISVILLE INC

Approval Date: 02/03/2025
Drug Name: ONAPGONDA #214056
Active Ingredients: APOMORPHINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MDD US

Approval Date: 02/07/2025
Drug Name: EMBLAVEONDA #217906
Active Ingredients: AVIBACTAM SODIUM; AZTREONAM
Submission Classification*: Type 4 - New Combination
Review Priority**: Priority
Company: ABBVIE

Approval Date: 02/11/2025
Drug Name: EVRYSDINDA #219285
Active Ingredients: RISDIPLAM
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: GENENTECH INC

Approval Date: 02/11/2025
Drug Name: GOMEKLINDA #219379
Active Ingredients: MIRDAMETINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SPRINGWORKS

Approval Date: 02/11/2025
Drug Name: GOMEKLINDA #219389
Active Ingredients: MIRDAMETINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SPRINGWORKS

Approval Date: 02/13/2025
Drug Name: DENOSUMAB-DSSBBLA #761392
Active Ingredients: DENOSUMAB-DSSB
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD

Approval Date: 02/13/2025
Drug Name: OSPOMYVBLA #761392
Active Ingredients: DENOSUMAB-DSSB
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD

Approval Date: 02/13/2025
Drug Name: XBRYKBLA #761392
Active Ingredients: DENOSUMAB-DSSB
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD

Approval Date: 02/14/2025
Drug Name: ROMVIMZANDA #219304
Active Ingredients: VIMSELTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: DECIPHERA PHARMS

Approval Date: 02/14/2025
Drug Name: MERILOGBLA #761325
Active Ingredients: INSULIN ASPART-SZJJ
Submission Classification*:
Review Priority**:
Company: SANOFI-AVENTIS U.S. LLC

Approval Date: 02/14/2025
Drug Name: MERILOG SOLOSTARBLA #761325
Active Ingredients: INSULIN ASPART-SZJJ
Submission Classification*:
Review Priority**:
Company: SANOFI-AVENTIS U.S. LLC

Approval Date: 02/19/2025
Drug Name: NILOTINIB D-TARTRATENDA #218922
Active Ingredients: NILOTINIB D-TARTRATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CIPLA

Approval Date: 02/21/2025
Drug Name: DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDENDA #218038
Active Ingredients: DILTIAZEM HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HQ SPCLT PHARMA

Approval Date: 02/21/2025
Drug Name: CTEXLINDA #219488
Active Ingredients: CHENODIOL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: MIRUM

Approval Date: 02/24/2025
Drug Name: MIUDELLANDA #218201
Active Ingredients: COPPER
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SEBELA WOMENS HEALTH INC

Approval Date: 02/28/2025
Drug Name: EPINEPHRINENDA #218475
Active Ingredients: EPINEPHRINE;SODIUMCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: BAXTER HLTHCARE CORP

Approval Date: 02/28/2025
Drug Name: STOBOCLOBLA #761404
Active Ingredients: DENOSUMAB-BMWO
Submission Classification*:
Review Priority**:
Company: CELLTRION INC

Study: Sponsors often submit different clinical evidence to FDA, EMA, for cell and gene therapies (published 03-Feb-2025)
Read Article on RAPS.org

MHRA drafts mRNA cancer immunotherapy guidance (published 03-Feb-2025)
Read Article on RAPS.org

Stakeholders seek more in-person meetings and faster guidance development from FDA (published 06-Feb-2025)
Read Article on RAPS.org

EMA adopts guideline on requirements for clinical-stage ATMPs (published 07-Feb-2025)
Read Article on RAPS.org

Trump's 10-for-1 order puts pressure on FDA to find regulations to nix (published 07-Feb-2025)
Read Article on RAPS.org

Drugmakers receive FDA warning letter for cGMP violations, failure to obtain IND approval (published 11-Feb-2025)
Read Article on RAPS.org

EMA’s revised reflection paper offers ‘snapshot’ of animal testing alternatives (published 13-Feb-2025)
Read Article on RAPS.org

EMA proposes new guideline on model-informed drug development (published 14-Feb-2025)
Read Article on RAPS.org

Stakeholders seek clarity, case studies on patient experience data in applications (published 17-Feb-2025)
Read Article on RAPS.org

Warning letters issued for cGMP violations, refusing entry, and falsifying documents (published 18-Feb-2025)
Read Article on RAPS.org

Wilson Bryan: Return-to-office mandate will weaken FDA, impact hiring (published 20-Feb-2025)
Read Article on RAPS.org

FDA rehires some laid-off staff, though some fear lasting damage to trust (published 24-Feb-2025)
Read Article on RAPS.org

Stakeholders seek clarification, flexibility, expansion of CGT guidance (published 25-Feb-2025)
Read Article on RAPS.org

EMA publishes work plans for infectious diseases and oncology (published 25-Feb-2025)
Read Article on RAPS.org

FDA, industry look to revisit regulatory framework for HCT/Ps (published 26-Feb-2025)
Read Article on RAPS.org

Stakeholders take issue with FDA’s guidance on drugs with mutagenic potential (published 28-Feb-2025)
Read Article on RAPS.org

• Review the recording from our webinar: Align New Oncology Drug Development with FDA's Project FrontRunner
• Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
• Read our infographic to learn more about the different types of meetings under BsUFA FDA Meeting Types for Biosimilar Products
• Download the Infographic explaining the Types of FDA Meetings with CDER and CBER

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.