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Connect with Veristat at Bio International Convention 2026
June 22-25, 2026 – San Diego, CA
🌎 Bringing the Global Biopharma Community Together
We’re delighted to be attending...
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This June 2026 regulatory update focuses on advancing innovative drug development through updated guidance on model-informed development, gene therapies, clinical trial design, and evidence generation. Key regulatory trends included increased use of AI, real-world evidence, digital health technologies, and reduced reliance on animal testing, alongside continued emphasis on quality and CGMP compliance. FDA also approved eight new drug and biologic products and announced upcoming advisory committee meetings on compounding and cell and gene therapies.
FDA Final Guidance:
M15 General Principles for Model-Informed Drug Development (Published 03-Jun-2026) | Download FDA Guidance
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug (Published 17-Jun-2026) | Download FDA Guidance
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus (Published 29-Jun-2026) | Download FDA Guidance
FDA Draft Guidance:
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing (Published 03-Jun-2026) | Draft FDA Guidance
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials (Published 25-Jun-2026) | Draft FDA Guidance
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (Published 25-Jun-2026) | Draft FDA Guidance
Master Protocols for Drug and Biological Product Development (Published 25-Jun-2026) | Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 06/02/2026
Drug Name: TIOCYSTINNDA #212927
Active Ingredients: TIOPRONIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: CASPER PHARMA LLC
Approval Date: 06/02/2026
Drug Name: RANLUSPECBLA #761480
Active Ingredients: RANIBIZUMAB-HKDZ
Submission Classification*:
Review Priority**:
Company: LUPIN LIMITED
Approval Date: 06/12/2026
Drug Name: AMBELVISTNDA #219627
Active Ingredients: GADOQUATRANE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BAYER HEALTHCARE
Approval Date: 06/16/2026
Drug Name: APREPITANTNDA #218754
Active Ingredients: APREPITANT
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AZURITY
Approval Date: 06/17/2026
Drug Name: UTEBZINDA #215960
Active Ingredients: TEBIPENEM PIVOXIL HYDROBROMIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: GLAXOSMITHKLINE
Approval Date: 06/24/2026
Drug Name: NAVITRUXNDA #220436
Active Ingredients: FOSAPREPITANT
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AVYXA HOLDINGS
Approval Date: 06/26/2026
Drug Name: LUMVOABLA #761530
Active Ingredients: VELIGROTUG-VVZE
Submission Classification*:
Review Priority**:
Company: VIRIDIAN THERAPEUTICS INC
Approval Date: 06/29/2026
Drug Name: ABANTANDA #221024
Active Ingredients: APIXABAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY
Upcoming Advisory Board Meetings
23-Jul-2026/ 24-Jul-2026: Pharmacy Compounding Advisory Committee Meeting- 08:00 AM EDT- 03:50 PM EDT
29-Jul-2026: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting- 10:00 AM EDT- 04:30 PM EDT
FDA, industry discuss need for flexibility in early phase clinical development of cell therapy products (Published 01-Jun-2026) | Read article on RAPS.org
FDA oncology draft guidance aims to reduce animal testing (Published 01-Jun-2026) | Read article on RAPS.org
Study: FDA approves more orphan drugs with specific cancer, pediatric indications over EMA (Published 02-Jun-2026) | Read article on RAPS.org
FDA aims to speed gene therapy development with prior scientific knowledge guidance (Published 02-Jun-2026) | Read article on RAPS.org
FDA updates manufacturer communications guidance to emphasize application to devices (Published 03-Jun-2026) | Read article on RAPS.org
FDA warns drugmakers for GMP and BIMO violations, records refusal (Published 04-Jun-2026) | Read article on RAPS.org
Stakeholders offer suggestions for improving FDA’s CNPV program (Published 04-Jun-2026) | Read article on RAPS.org
Industry groups seek more flexibility for DHTs in clinical trials (Published 08-Jun-2026) | Read article on RAPS.org
ICH adopts GCP Annex 2, announces progress on other guidelines (Published 08-Jun-2026) | Read article on RAPS.org
Study: Patients favor accelerated approval for oncology drugs without alternatives (Published 09-Jun-2026) | Read article on RAPS.org
Pharma groups say SUPAC guidelines should be updated, better aligned with ICH (Published 09-Jun-2026) | Read article on RAPS.org
USP: Drug shortages declined in 2025 but are lasting longer (Published 10-Jun-2026) | Read article on RAPS.org
Risk management systems should be constantly evolving, FDA official says (Published 10-Jun-2026) | Read article on RAPS.org
Experts outline considerations for pivotal trial designs for new CGTs (Published 12-Jun-2026) | Read article on RAPS.org
FDA issues guidance on sharing potential NDA patent information (Published 15-Jun-2026) | Read article on RAPS.org
DIA: FDA officials discuss trends in AI, RWE in submissions (Published 17-Jun-2026) | Read article on RAPS.org
Study: Regulators often diverge from FDA on expedited oncology approvals (Published 22-Jun-2026) | Read article on RAPS.org
FDA revises master protocol guidance with new section on basket trials (Published 22-Jun-2026) | Read article on RAPS.org
FDA cites Amazon and others for selling unapproved drugs, drugmakers for CGMP violations (Published 23-Jun-2026) | Read article on RAPS.org
HHS and FDA propose clinical trial reforms to expedite drug development (Published 23-Jun-2026) | Read article on RAPS.org
Industry asks FDA for harmonization, clarification in fermentation, semi-synthetic antibiotics guidance (Published 24-Jun-2026) | Read article on RAPS.org
Experts say FDA’s plan to reduce animal testing is already seeing success at 1 year, but challenges remain (Published 25-Jun-2026) | Read article on RAPS.org
Pinnacle cited by FDA for failing to balance risks and benefits in video ads (Published 25-Jun-2026) | Read article on RAPS.org
WHO issues guideline to curb environmental waste in pharmaceutical manufacturing (Published 26-Jun-2026) | Read article on RAPS.org
FDA cites drug firms for CGMP violations, failing to provide records (Published 30-Jun-2026) | 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.
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.