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This July 2026 regulatory update focuses on the FDA finalizing six guidances that addresses antiviral next-generation sequencing data, psychedelic drug trials, topical corticosteroid bioequivalence, and broader cancer-trial eligibility, while issuing draft guidance on container and device considerations for biosimilars. July RAPs Regulatory news focused on AI and NGS policy, manufacturing and quality oversight, drug repurposing, oncology approvals and access, advertising enforcement, orphan-drug rules, and calls for greater FDA transparency. FDA also approved 18 products, which includes four priority-reviewed new molecular entities. Finally, there is a Pediatric Advisory Committee meeting scheduled for September 16, 2026.
FDA Final Guidance:
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products (01-Jul-2026) | Download FDA Guidance
Psychedelic Drugs: Considerations for Clinical Investigations (13-Jul-2026) | Download FDA Guidance
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (14-Jul-2026) | Download FDA Guidance
Cancer Clinical Trial Eligibility Criteria: Performance Status (27-Jul-2026) | Download FDA Guidance
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications (27-Jul-2026) | Download FDA Guidance
Cancer Clinical Trial Eligibility Criteria: Laboratory Values (27-Jul-2026) | Download FDA Guidance
FDA Draft Guidance:
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts (31-Jul-2026) | Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 07/07/2026
Drug Name: TRUTAKNABLA #761486
Active Ingredients: ATACICEPT-VYMJ
Submission Classification*:
Review Priority**:
Company: VERA THERAPEUTICS INC.
Approval Date: 07/09/2026
Drug Name: SODIUM BICARBONATENDA #220790
Active Ingredients: SODIUM BICARBONATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMNEAL
Approval Date: 07/09/2026
Drug Name: SARCLISA ESCENABLA #761445
Active Ingredients: ISATUXIMAB-IRFC
Submission Classification*:
Review Priority**:
Company: SANOFI-AVENTIS U.S. LLC
Approval Date: 07/10/2026
Drug Name: ZYOGREENNDA #218579
Active Ingredients: INDOCYANINE GREEN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: PROVEPHARM SAS
Approval Date: 07/14/2026
Drug Name: REVTORPYKNDA #219908
Active Ingredients: GEDATOLISIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: CELCUITY
Approval Date: 07/15/2026
Drug Name: LIPFENDRANDA #220848
Active Ingredients: ENLICITIDE DECANOATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: MSD
Approval Date: 07/17/2026
Drug Name: EDARAVONENDA #221059
Active Ingredients: EDARAVONE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY PHARMACEUTICALS INC
Approval Date: 07/19/2026
Drug Name: AIRNDA #221805
Active Ingredients: AIR
Submission Classification*:
Review Priority**: Unknown
Company: NOBLE GAS SOLUTIONS INC.
Approval Date: 07/20/2026
Drug Name: SCOMARANDA #218528
Active Ingredients: SIROLIMUS
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AFT PHARMACEUTICALS LTD
Approval Date: 07/22/2026
Drug Name: JIDEYTRONDA #220185
Active Ingredients: ZIDESAMTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: NUVALENT INC
Approval Date: 07/24/2026
Drug Name: SIMTRIYONDA #218145
Active Ingredients: CENTANAFADINE HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: OTSUKA PHARMACEUTICAL CO LTD
Approval Date: 07/24/2026
Drug Name: TYLENOL WITH NAPROXENNDA #219962
Active Ingredients: NAPROXEN SODIUM, ACETAMINOPHEN
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: KENVUE BRANDS LLC
Approval Date: 07/24/2026
Drug Name: LYTENAVABLA #761320
Active Ingredients: BEVACIZUMAB-VIKG
Submission Classification*:
Review Priority**:
Company: OUTLOOK THERAPEUTICS, INC.
Approval Date: 07/24/2026
Drug Name: GARZULYSBLA #761497
Active Ingredients: INSULIN ASPART-FSAN
Submission Classification*:
Review Priority**:
Company: EMERGE BIOSCIENCE PTE. LTD.
Approval Date: 07/28/2026
Drug Name: GWYN LONDA #219990
Active Ingredients: NORELGESTROMIN || ETHINYL ESTRADIOL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: VIATRIS SPECIALTY
Approval Date: 07/29/2026
Drug Name: RuxolitinibNDA #219660
Active Ingredients: Ruxolitinib
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: APOTEX
Approval Date: 07/29/2026
Drug Name: GLYCOPHOSNDA #220381
Active Ingredients: SODIUM GLYCEROPHOSPHATE
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: FRESENIUS KABI USA LLC
Approval Date: 07/29/2026
Drug Name: QLONILIKNDA #221094
Active Ingredients: CLONIDINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: CMP DEV LLC
Upcoming Advisory Board Meetings
16-Sep-2026: Pediatric Advisory Committee Meeting- 10:00 AM EDT- 04:00 PM EDT
Global regulations governing orphan drug designation (Published 01-Jul-2026) | Read article on RAPS.org
FDA asked to clarify AI pilot objectives for early-phase clinical trials (Published 01-Jul-2026) | Read article on RAPS.org
Industry groups press FDA for transparency, next steps for CNPV program (Published 07-Jul-2026) | Read article on RAPS.org
FDA proposes rule to ease registration for distributed manufacturers, require foreign API sites to register (Published 10-Jul-2026) | Read article on RAPS.org
Psychedelics: FDA offers clarifications, compromises in final clinical trial guidance (Published 13-Jul-2026) | Read article on RAPS.org
Diamantas backtracks on Makary’s policies issued in journal articles (Published 15-Jul-2026) | Read article on RAPS.org
CDER plans new guidance on AI, electronic safety report submissions, and more (Published 16-Jul-2026) | Read article on RAPS.org
Industry wants more clarity on NGS for assessing gene therapy safety (Published 17-Jul-2026) | Read article on RAPS.org
Why quality issues keep coming back — and how to stop them for good (Published 20-Jul-2026) | Read article on RAPS.org
Study: China outpaces the US in cancer approvals, lags behind on first approvals (Published 20-Jul-2026) | Read article on RAPS.org
FDA issues untitled letters to Sanofi and Viatris for false advertising (Published 22-Jul-2026) | Read article on RAPS.org
Study: Most sponsors complete postmarketing trials, publish results (Published 23-Jul-2026) | Read article on RAPS.org
FDA advisory committee backs two controversial peptides (Published 23-Jul-2026) | Read article on RAPS.org
Researchers find similar drug development to reimbursement timelines for major markets (Published 27-Jul-2026) | Read article on RAPS.org
FDA finalizes three guidances to broaden cancer clinical trial eligibility (Published 27-Jul-2026) | Read article on RAPS.org
Researchers concerned by underutilization of accelerated approval in oncology (Published 30-Jul-2026) | Read article on RAPS.org
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.