Monthly FDA Guidance and Regulatory News Review - July 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:

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry (published 18-Jul-2025)
Download FDA Guidance

FDA Draft Guidance:

Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment (published 02-Jul-2025)
Draft FDA Guidance

Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations (published 03-Jul-2025)
Draft FDA Guidance

Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen (published 15-July-2025)
Draft FDA Guidance

Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects (published 17-July-2025)
Draft FDA Guidance

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials (published 21-July-2025)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 07/02/2025
Drug Name: ZEGFROVYNDA #219839
Active Ingredients: SUNVOZERTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: DIZAL JIANGSU

Approval Date: 07/02/2025
Drug Name: LYNOZYFICBLA #761400
Active Ingredients: LINVOSELTAMAB-GCPT
Submission Classification*:
Review Priority**:
Company: RENGENERON PHARMACEUTICALS, INC.

Approval Date: 07/03/2025
Drug Name: BENDAMUSTINE HYDROCHLORIDENDA #219014
Active Ingredients: BENDAMUSTINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: DR REDDYS

Approval Date: 07/03/2025
Drug Name: EKTERLYNDA #219301
Active Ingredients: SEBETRALSTAT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: KALVISTA

Approval Date: 07/15/2025
Drug Name: KIRSTYBLA #761188
Active Ingredients: INSULIN ASPART-XJHZ
Submission Classification*:
Review Priority**:
Company: BIOCON BIOLOGICS INC

Approval Date: 07/16/2025
Drug Name: FAMOTIDINENDA #219935
Active Ingredients: FAMOTIDINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SAGENT

Approval Date: 07/23/2025
Drug Name: ANZUPGONDA #219155
Active Ingredients: DELGOCITINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: LEO PHARMA AS

Approval Date: 07/23/2025
Drug Name: VOSTALLYNDA #219757
Active Ingredients: RAMIPRIL
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ROSEMONT PHARMACEUTICALS INC

Approval Date: 07/24/2025
Drug Name: SDAMLONDA #219531
Active Ingredients: AMLODIPINE BESYLATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: BRILLIAN PHARMA INC

Approval Date: 07/24/2025
Drug Name: DOPTELET SPRINKLENDA #219696
Active Ingredients: AVATROMBOPAG MALEATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AKARX INC

Approval Date: 07/28/2025
Drug Name: SEPHIENCENDA #219666
Active Ingredients: SEPIAPTERIN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: PTC THERAP

Approval Date: 07/29/2025
Drug Name: VYSCOXANDA #211759
Active Ingredients: CELECOXIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CODADOSE INC

Approval Date: 07/30/2025
Drug Name: ATMEKSINDA #219843
Active Ingredients: METHOCARBAMOL
Submission Classification*:
Review Priority**: Standard
Company: ROSEMONT PHARMACEUTICALS INC

Approval Date: 07/31/2025
Drug Name: VIZZNDA #218585
Active Ingredients: ACECLIDINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: LENZ THERAPEUTICS INC

Approval Date: 07/31/2025
Drug Name: ALHEMOBLA #761428
Active Ingredients: CONCIZUMAB
Submission Classification*:
Review Priority**:
Company: NOVO NORDISK INC

Upcoming Advisory Board Meetings

N/A

New label requirement for ADHD stimulants warns of weight-loss risk in young children (published 01-Jul-2025)
Read Article on RAPS.org

EMA reports uptick in RWD studies, growth in DARWIN network (published 02-Jul-2025)
Read Article on RAPS.org

FDA proposes clinical trial, endpoint considerations in MDS drug development guidance (published 07-Jul-2025)
Read Article on RAPS.org

Parenteral drugs: FDA replaces guidance on aluminum content limits (published 07-Jul-2025)
Read Article on RAPS.org

Study: FDA more likely to approve drugs for broader populations than EMA, Swissmedic (published 08-Jul-2025)
Read Article on RAPS.org

FDA, NIH officials look to curb animal testing in drug development (published 08-Jul-2025)
Read Article on RAPS.org

European Commission proposes on updated GMP guidelines for AI (published 09-Jul-2025)
Read Article on RAPS.org

EU expert group established for pediatric and rare disease devices (published 09-Jul-2025)
Read Article on RAPS.org

FDA publishes 200 complete response letters in transparency effort (published 10-Jul-2025)
Read Article on RAPS.org

Makary lauds user fees as FDA begins GDUFA IV reauthorization process (published 11-Jul-2025)
Read Article on RAPS.org

Study: Most nononcology accelerated approval pivotal trials use surrogate endpoints (published 15-Jul-2025)
Read Article on RAPS.org

FDA warns wearable tech firm, Korean drugmaker, and sellers of Kratom-derived compound (published 15-Jul-2025)
Read Article on RAPS.org

UK sets plan to be Euro life sciences leader by 2030 (published 16-Jun-2025)
Read Article on RAPS.org

FDA issues guidance on developing cancer drugs in combination with other treatments (published 16-Jun-2025)
Read Article on RAPS.org

Panel urges FDA to remove boxed warning on women’s hormone therapy (published 17-Jul-2025)
Read Article on RAPS.org

FDA finalizes guidance for efficient biosimilars meetings, per BsUFA III (published 18-Jun-2025)
Read Article on RAPS.org

FDA panel debates label change on SSRI use during pregnancy (published 21-Jun-2025)
Read Article on RAPS.org

FDA names biotech entrepreneur, Stanford professor as new CDER chief (published 21-Jul-2025)
Read Article on RAPS.org

MHRA to move forward with medical device reliance plans (published 22-Jul-2025)
Read Article on RAPS.org

FDA warns Glenmark for failure to investigate dissolution failures (published 22-Jul-2025)
Read Article on RAPS.org

Questions remain as FDA opens submissions for new priority voucher program (published 24-Jul-2025)
Read Article on RAPS.org

EMA: Drug repurposing efforts saw limited success during pilot (published 24-Jul-2025)
Read Article on RAPS.org

FDA white paper encourages adoption of selective safety data collection (published 25-Jul-2025)
Read Article on RAPS.org

EMA proposes reflection paper on using external controls to generate evidence (published 25-Jun-2025)
Read Article on RAPS.org

7-year FDA review finds improved GCP compliance (published 28-Jul-2025)
Read Article on RAPS.org

FDA, ASCO propose principles for proper dosing in cancer drug development (published 28-Jul-2025)
Read Article on RAPS.org

Manufacturers largely met May DSCSA deadline without major issues, experts say (published 29-Jul-2025)
Read Article on RAPS.org

Experts offer advice on avoiding common warning letter citations (published 29-Jul-2025)
Read Article on RAPS.org

FDA unveils FY 2026 user fee rates (published 29-Jul-2025)
Read Article on RAPS.org

FDA warns firms for CGMP, QSR violations; online retailers cited for selling unapproved drugs (published 31-Jul-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.