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This September 2026 regulatory update focuses on FDA’s new guidance on neonatal parenteral nutrition compounding and blood component manufacturing, alongside draft guidance on evaluating hepatic impairment’s effects on drug pharmacokinetics and dosing. Key industry developments include evolving FDA and EMA policies on digital endpoints, alternative testing methods, expedited clinical trials, electronic product information, combination products, and biosimilar reviews. The FDA reported multiple drug and biologic approvals throughout September, including new molecular entities and new formulations, with the next Dermatologic and Ophthalmic Drugs Advisory Committee meeting scheduled for October 30, 2026.
FDA Final Guidance:
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for Industry (Published 08-Sep-2026) | Download FDA Guidance
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method (Published 16-Sep-2026) | Download FDA Guidance
FDA Draft Guidance:
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing (Published 02-Sep-2026) | Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 09/03/2026
Drug Name: ZANVASTRONDA #220210
Active Ingredients: ZILGANERSEN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: IONIS PHARMS INC
Approval Date: 09/03/2026
Drug Name: OMCAZIONDA #220613
Active Ingredients: CABOZANTINIB LAURYLSULFATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HANDA ONCOL
Approval Date: 09/04/2026
Drug Name: ETCAMAHNDA #220359
Active Ingredients: CAMIZESTRANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ASTRAZENECA
Approval Date: 09/11/2026
Drug Name: PIXCLARANDA #218592
Active Ingredients: FLORETYROSINE F-18
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: TELIX
Approval Date: 09/11/2026
Drug Name: ISEMBYLDBLA #761463
Active Ingredients: APITEGROMAB-MSTN
Submission Classification*:
Review Priority**:
Company: SCHOLAR ROCK INC
Approval Date: 09/14/2026
Drug Name: BEXLUTRYNDA #218525
Active Ingredients: LUTETIUM LU-177 DOTATATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: CURIUM
Approval Date: 09/17/2026
Drug Name: EMPAGLIFLOZINNDA #220758
Active Ingredients: EMPAGLIFLOZIN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: RIDHISIDHI, PLLC
Approval Date: 09/22/2026
Drug Name: CARBON DIOXIDE, USPNDA #222000
Active Ingredients: CARBON DIOXIDE, USP
Submission Classification*:
Review Priority**: Unknown
Company: AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES
Approval Date: 09/23/2026
Drug Name: LYRFIGTUNDA #220425
Active Ingredients: LIRAFUGRATINIB HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ELEVAR THERAPEUTICS INC
Approval Date: 09/23/2026
Drug Name: ONSWIKBLA #761408
Active Ingredients: INSULIN EFSITORA ALFA-GOBE
Submission Classification*:
Review Priority**:
Company: ELI LILLY AND CO
Approval Date: 09/25/2026
Drug Name: ZUEINONDA #218379
Active Ingredients: DICLOFENAC SODIUM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ADVENTAPHARMA DWC LLC
Approval Date: 09/25/2026
Drug Name: JUVMONDA #220415
Active Ingredients: TAVAPADON
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ABBVIE INC
Approval Date: 09/25/2026
Drug Name: APIXABANNDA #220446
Active Ingredients: APIXABAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: LUPIN
Approval Date: 09/25/2026
Drug Name: ATEBRIOZNDA #221198
Active Ingredients: ZILURGISERTIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: INCYTE CORP
Approval Date: 09/25/2026
Drug Name: DEGEVMABLA #761481
Active Ingredients: DENOSUMAB-ADET
Submission Classification*:
Review Priority**:
Company: TEVA PHARMACEUTICALS, INC.
Approval Date: 09/28/2026
Drug Name: EMCITATENDA #220963
Active Ingredients: TIRATRICOL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: RARE THYROID THERAPEUTICS INTERNATIONAL AB
Upcoming Advisory Board Meetings
30-Oct-2026: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting- 08:30 AM EDT- 03:00 PM EDT
FDA drafts guidance on assessing impact of hepatic impairment on drug PK/PD (Published 01-Sep-2026) | Read article on RAPS.org
FDA officials review best practices for validating digitally derived endpoints (Published 01-Sep-2026) | Read article on RAPS.org
EMA launches data sharing pilot to gain confidence in NAMs, reduce animal testing (Published 02-Sep-2026) | Read article on RAPS.org
Industry asks FDA to expand prior knowledge guidance (Published 03-Sep-2026) | Read article on RAPS.org
EMA issues guidance on submitting ePI ahead of upcoming requirement (Published 08-Sep-2026) | Read article on RAPS.org
FDA names permanent CDER, CBER directors, new deputy commissioner for AI (Published 09-Sep-2026) | Read article on RAPS.org
Sujith Kallur Mallikarjuna wants to change the way we talk about combination products (Published 10-Sep-2026) | Read article on RAPS.org
FDA to consider ‘innovative approaches’ to psychedelic drug development (Published 10-Sep-2026) | Read article on RAPS.org
How to learn about biologics CMC: advice on technical issues, regulatory strategy, and more (Published 10-Sep-2026) | Read article on RAPS.org
Optimizing EDDO control strategies for drug/biologic combination products (Published 15-Sep-2026) | Read article on RAPS.org
FDA to test new approach to expediting Phase 1 trials (Published 15-Sep-2026) | Read article on RAPS.org
Graham: PDUFA VIII reflects ‘America First’ principles (Published 17-Sep-2026) | Read article on RAPS.org
FDA to remove ‘animal testing’ terminology from its regulations (Published 21-Sep-2026) | Read article on RAPS.org
Distributed manufacturing: Industry groups weigh in on FDA’s proposed rule (Published 23-Sep-2026) | Read article on RAPS.org
Recon: FDA approves drugs for Parkinson’s, bile duct cancer, rare soft tissue disease; Merck, Daiichi scrap application for ADC in lung cancer (Published 28-Sep-2026) | Read article on RAPS.org
BsUFA commitment letter outlines changes to FDA’s biosimilar review program (Published 28-Sep-2026) | Read article on RAPS.org
FDA draft guidance addresses considerations for robotically assisted surgical devices (Published 29-Sep-2026) | Read article on RAPS.org
Taylor Mulkerin
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.