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Meet Veristat at BIO-Europe Spring: March 23-25, 2026 - Lisbon, Portugal
🔬 Connecting with the Global Biopharma Community
Veristat is pleased to attend BIO-Europe Spring, where biotech...
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In February 2026, FDA activity included new draft guidances, regulatory initiatives (e.g., PreCheck and eCTD 4.0), continued focus on innovation areas like rare diseases and AI, multiple drug approvals (including new molecular entities), and an upcoming Oncology Advisory Committee meeting.
FDA Final Guidance:
N/A
FDA Draft Guidance:
E22 General Considerations for Patient Preference Studies (published 02-Feb-2026)
Draft FDA Guidance
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause | FDA
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 02/02/2026
Drug Name: AIRNDA #221287
Active Ingredients: AIR
Submission Classification*:
Review Priority**: Unknown
Company: GENERAL AIR SERVICE & SUPPLY COMPANY
Approval Date: 02/03/2026
Drug Name: VYKOURANDA #220406
Active Ingredients: LEUCOVORIN CALCIUM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AVYXA HOLDINGS
Approval Date: 02/12/2026
Drug Name: ADQUEYNDA #219474
Active Ingredients: DIFAMILAST
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ACROTECH BIOPHARMA
Approval Date: 02/13/2026
Drug Name: AVOPEFNDA #220200
Active Ingredients: ETOPOSIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AVYXA HOLDINGS
Approval Date: 02/13/2026
Drug Name: RYBREVANT FASPROBLA #761484
Active Ingredients: AMIVANTAMAB AND HYALURONIDASE-LPUJ
Submission Classification*:
Review Priority**:
Company: JANSSEN BIOTECH
Approval Date: 02/17/2026
Drug Name: MEDICAL AIR, USPNDA #221337
Active Ingredients:
Submission Classification*:
Review Priority**: Unknown
Company: INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC
Approval Date: 02/20/2026
Drug Name: FAVLYXANDA #220201
Active Ingredients: FLUOROURACIL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AVYXA HOLDINGS
Approval Date: 02/20/2026
Drug Name: BYSANTINDA #220358
Active Ingredients: MILSAPERIDONE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: VANDA PHARMS INC
Approval Date: 02/23/2026
Drug Name: LOARGYSBLA #761211
Active Ingredients: PEGZILARGINASE-NBLN
Submission Classification*:
Review Priority**:
Company: IMMEDICA PHARMA AB
Approval Date: 02/25/2026
Drug Name: DESMODANDA #219873
Active Ingredients: DESMOPRESSIN ACETATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ETON
Approval Date: 02/27/2026
Drug Name: DULOXETINE HYDROCHLORIDENDA #219131
Active Ingredients: DULOXETINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ALMATICA
Approval Date: 02/27/2026
Drug Name: YUVIWELNDA #219164
Active Ingredients: NAVEPEGRITIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ASCENDIS
Approval Date: 02/27/2026
Drug Name: PREZCOBIXNDA #220092
Active Ingredients: DARUNAVIR AND COBICISTAT
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: JANSSEN PRODS
Approval Date: 02/27/2026
Drug Name: PREZCOBIX PEDNDA #220092
Active Ingredients: COBICISTAT; DARUNAVIR ETHANOLATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: JANSSEN PRODS
Upcoming Advisory Board Meetings
12-Mar-2026: Vaccines and Related Biological Products Advisory Committee Meeting- 09:00 AM EDT- 3:30 PM EDT
FDA announces formal launch of PreCheck program (published 06-Feb-2026)
Read article on RAPS.org
FDA, EMA officials encourage companies to pilot eCTD 4.0 (published 03-Feb-2026)
Read article on RAPS.org
Pharma expert discusses effort to standardize CMC quality information (published 06-Feb-2026)
Read article on RAPS.org
ICH adopts M15 guideline on model-informed drug development (published 10-Feb-2026)
Read article on RAPS.org
FDA approves labeling changes for six menopausal hormone therapy products (published 12-Feb-2026)
Read article on RAPS.org
EMA said stepwise PIP pilot is feasible in expediting pediatric drug development (published 13-Feb-2026)
Read article on RAPS.org
EU pharmaceutical groups suggest fixes to ICH E20 guideline (published 16-Feb-2026)
Read article on RAPS.org
Industry clamors for clearer guidance on transition to ICH M4Q(R2) (published 23-Feb-2026)
Read article on RAPS.org
Makary touts FDA speed, flexibility for rare disease drugs (published 24-Feb-2026)
Read article on RAPS.org
FDA’s CDER agenda includes new guidance on digital health technologies and AI in manufacturing (published 25-Feb-2026)
Read article on RAPS.org
FDA’s handling of rare disease therapies criticized in Senate hearing (published 26-Feb-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.