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This May 2026 regulatory update highlights multiple guidances issued by the FDA across cell and gene therapy, clinical development, and pharmaceutical quality. The FDA also released new draft guidances focused on pain management, stimulant use disorders, and oncology products. Key regulatory updates included AI adoption, inspection and manufacturing initiatives, GMP enforcement actions, and several notable drug and biologic approvals.
FDA Final Guidance:
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application (Published 05-May-2026)
Download FDA Guidance
Submitting Continuous Glucose Monitoring Data in Clinical Trials (Published 07-May-2026)
Download FDA Guidance
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention (Published 08-May-2026)
Download FDA Guidance
Postapproval Pregnancy Safety Studies (Published 08-May-2026)
Download FDA Guidance
Pulmonary Tuberculosis: Developing Drugs for Treatment (Published 08-May-2026)
Download FDA Guidance
M11 Clinical Electronic Structured Harmonised Protocol (Published 22-May-2026)
Download FDA Guidance
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (Published 20-May-2026)
Download FDA Guidance
Q8, Q9, and Q10 Questions and Answers (R5) (Published 29-May-2026)
Download FDA Guidance
FDA Draft Guidance:
Development of Non-Opioid Analgesics for Chronic Pain (Published 13-May-2026) Draft FDA Guidance
Stimulant Use Disorders: Developing Drugs for Treatment (Published 13-May-2026) Draft FDA Guidance
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect (Published 13-May-2026) Draft FDA Guidance
Development of Non-Opioid Analgesics for Acute Pain (Published 13-May-2026) Draft FDA Guidance
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework (Published 13-May-2026) Draft FDA Guidance
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products (Published 29-May-26) Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 05/01/2026
Drug Name: JAKAFI XRNDA #217180
Active Ingredients: RUXOLITINIB PHOSPHATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: INCYTE CORP
Approval Date: 05/01/2026
Drug Name: VEPPANUNDA #219835
Active Ingredients: VEPDEGESTRANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ARVINAS OPERATIONS
Approval Date: 05/01/2026
Drug Name: EVDINDA #220837
Active Ingredients: TRABECTEDIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: APOTEX
Approval Date: 05/07/2026
Drug Name: DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATENDA #219804
Active Ingredients: DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: ASPEN SA OPERATIONS (PTY) LTD
Approval Date: 05/07/2026
Drug Name: ENNUMOBLA #761147
Active Ingredients: PEGFILGRASTIM-PCCG
Submission Classification*:
Review Priority**:
Company: ACCORD BIOPHARMA INC.
Approval Date: 05/13/2026
Drug Name: BEQALZINDA #220711
Active Ingredients: SONROTOCLAX
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BEONE MEDICINES USA
Approval Date: 05/14/2026
Drug Name: TRIMBOWNDA #219622
Active Ingredients: BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: CHIESI
Approval Date: 05/15/2026
Drug Name: BAXFENDYNDA #219878
Active Ingredients: BAXDROSTAT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ASTRAZENECA AB
Approval Date: 05/15/2026
Drug Name: IMMGOLISBLA #761452
Active Ingredients: GOLIMUMAB-SLDI
Submission Classification*:
Review Priority**:
Company: ACCORD BIOPHARMA INC.
Approval Date: 05/15/2026
Drug Name: IMMGOLIS INTRIBLA #761452
Active Ingredients: GOLIMUMAB-SLDI
Submission Classification*:
Review Priority**:
Company: ACCORD BIOPHARMA INC.
Approval Date: 05/22/2026
Drug Name: DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)NDA #220736
Active Ingredients: ADAPALENE, BENZOYL PEROXIDE
Submission Classification*: Type 8 - Partial Rx to OTC Switch
Review Priority**: Standard
Company: GALDERMA LABORATORIES, L.P
Approval Date: 05/22/2026
Drug Name: HEPCLUDEXBLA #761468
Active Ingredients: BULEVIRTIDE-GMOD
Submission Classification*:
Review Priority**:
Company: GILEAD SCIENCES INC
Approval Date: 05/27/2026
Drug Name: DECNUPAZBLA #761460
Active Ingredients: PIVEKIMAB SUNIRINE-PVZY
Submission Classification*:
Review Priority**:
Company: ABBVIE INC
Approval Date: 05/29/2026
Drug Name: ZAYNICHNDA #220787
Active Ingredients: ZIDEBACTAM AND CEFEPIME
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Priority
Company: WOCKHARDT BIO AG
Upcoming Advisory Board Meetings
18-Jun-2026: Vaccines and Related Biological Products Advisory Committee Meeting- 08:30 AM EDT- 04:00 PM EDT
23-Jul-2026/ 24-Jul-2026: Pharmacy Compounding Advisory Committee Meeting- 08:00 AM EDT- 03:50 PM EDT
FDA cites firms for CGMP violations, failure to submit PMA application (Published 05-May-2026) | Read article on Raps.org
Makary announces one-day inspection pilot for low-risk facilities (Published 06-May-2026) | Read article on Raps.org
FDA officials discuss new AI tool HALO, other applications of AI (Published 07-May-2026) | Read article on Raps.org
FDA finalizes guidance on CMC flexibilities for cell and gene therapies (Published 08-May-2026) | Read article on Raps.org
FDA finalizes guidance on designing pregnancy safety studies (Published 11-May-2026) | Read article on Raps.org
FDA looks to repurposing older drugs for new uses (Published 12-May-2026) | Read article on Raps.org
Trump confirms Makary is out at FDA (Published 12-May-2026) | Read article on Raps.org
FDA warns researchers and drugmakers for clinical study, GMP violations (Published 19-May-2026) | Read article on Raps.org
FDA official offers examples of RWE being used to secure drug approval (Published 19-May-2026) | Read article on Raps.org
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program (Published 20-May-2026) | Read article on Raps.org
Industry says FDA’s guidance on animal testing alternatives needs work (Published 21-May-2026) | Read article on Raps.org
FDA warns drugmakers in US, Japan, and India for GMP issues (Published 26-May-2026) | Read article on Raps.org
FDA provides additional examples, clarity in human factors guidance (Published 28-May-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.