Monthly FDA Guidance and Regulatory News Review - August 2026

This August 2026 regulatory update focuses on the FDA finalizing three guidances addressing formal sponsor meetings, cell and gene therapy development, and therapeutic-equivalence evaluations, while issuing draft guidance on container-closure systems, ANDA versus 505(b)(2) applications, and immunotherapy potency assessments. August RAPS regulatory news focused on manufacturing and quality oversight, quantitative medicine, CMC digitization, reduced animal testing, rare-disease evidence, regulatory pathways, and GMP compliance. FDA also approved 11 products, including five priority-reviewed new molecular entities. Finally, Vaccines Advisory Committee meeting is scheduled for 01Oct26.

FDA Final Guidance:

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (Published 12-Aug-2026) | Download FDA Guidance

Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (Published 19-Aug-2026) | Download FDA Guidance

Evaluation of Therapeutic Equivalence (Published 21-Aug-2026) | Download FDA Guidance

FDA Draft Guidance:

Container Closure Systems for Human Drugs and Biological Products (Published 13-Aug-2026) | Draft FDA Guidance

Determining Whether to Submit an ANDA or a 505(b)(2) Application (Published 17-Aug-2026) | Draft FDA Guidance

Potency Assessment of Active Immunotherapy Products (Published 19-Aug-2026) | Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 08/05/2026

Drug Name: ORZEYFULNDA   #220860

Active Ingredients: OVEPOREXTON

Submission Classification*: Type 1 - New Molecular Entity

Review Priority**: Priority

Company: TAKEDA PHARMS USA

 

Approval Date: 08/09/2026

Drug Name: NITROUS OXIDE, USPNDA   #221892

Active Ingredients: NITROUS OXIDE

Submission Classification*:

Review Priority**: Unknown

Company: LINDE GAS EQUIP

 

Approval Date: 08/13/2026

Drug Name: TAUKLARIFYNDA   #220496

Active Ingredients: FLORQUINITAU F-18

Submission Classification*: Type 1 - New Molecular Entity

Review Priority**: Standard

Company: CERVEAU LANTHEUS

 

Approval Date: 08/13/2026

Drug Name: ZENBEXUSNDA   #221075

Active Ingredients: IBERDOMIDE HYDROCHLORIDE

Submission Classification*: Type 1 - New Molecular Entity

Review Priority**: Priority

Company: BRISTOL MYERS SQUIBB

 

Approval Date: 08/14/2026

Drug Name: SODIUM BICARBONATENDA   #218524

Active Ingredients: SODIUM BICARBONATE

Submission Classification*: Type 5 - New Formulation or New Manufacturer

Review Priority**: Standard

Company: BAXTER HLTHCARE CORP

 

Approval Date: 08/17/2026

Drug Name: SEHIPPYNDA   #218328

Active Ingredients: VORTIOXETINE

Submission Classification*: Type 2 - New Active Ingredient and Type 3 - New Dosage Form

Review Priority**: Standard

Company: SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD

 

Approval Date: 08/19/2026

Drug Name: PASATRUBLA   #761508

Active Ingredients: GARETOSMAB-GRTS

Submission Classification*:

Review Priority**:

Company: REGENERON PHARMACEUTICALS, INC

 

Approval Date: 08/26/2026

Drug Name: VOBRIGNDA   #213225

Active Ingredients: LEUPROLIDE ACETATE

Submission Classification*: Type 5 - New Formulation or New Manufacturer

Review Priority**: Standard

Company: SUN PHARM

 

Approval Date: 08/26/2026

Drug Name: RASONQUENDA   #220910

Active Ingredients: DARAXONRASIB

Submission Classification*: Type 1 - New Molecular Entity

Review Priority**: Priority

Company: REVOLUTION MEDICINES

 

Approval Date: 08/27/2026

Drug Name: LISRAYANDA   #220106

Active Ingredients: BREPOCITINIB TOSYLATE

Submission Classification*: Type 1 - New Molecular Entity

Review Priority**: Priority

Company: PRIOVANT THERAP

 

Approval Date: 08/27/2026

Drug Name: BIXLENVONDA   #221104

Active Ingredients: BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM

Submission Classification*: Type 4 - New Combination

Review Priority**: Priority

Company: GILEAD SCIENCES INC

 

Approval Date: 08/27/2026

Drug Name: BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)NDA   #221443

Active Ingredients: BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM

Submission Classification*: Type 4 - New Combination

Review Priority**: Standard

Company: GILEAD SCIENCES INC

 

Approval Date: 08/28/2026

Drug Name: MIMRYLONDA   #220605

Active Ingredients: RUSFERTIDE ACETATE

Submission Classification*: Type 1 - New Molecular Entity

Review Priority**: Priority

Company: TAKEDA PHARMS AM

Upcoming Advisory Board Meetings

01-Oct-2026: Vaccines and Related Biological Products Advisory Meeting- 09:00 AM EDT- 01:00 PM EDT

Expert sees shift to ecosystem-centric assurance under FDAs distributed manufacturing rule (Published 03-Aug-2026) |   Read article on RAPS.org

FDA updates TDS guidances on adhesive performance, skin irritation and sensitization studies (Published 03-Aug-2026) | Read article on RAPS.org

FDA seeks feedback on quantitative medicine network (Published 04-Aug-2026) | Read article on RAPS.org

EMA issues updated guidance on shortage prevention plans ahead of legal deadline (Published 07-Aug-2026) | Read article on RAPS.org

FDA finalizes guidance on formal meetings with drug and biologics sponsors (Published 14-Aug-2026) | Read article on RAPS.org

Experts propose safety framework for improving predictability, interpretation of CNS toxicity (Published 17-Aug-2026) | Read article on RAPS.org

FDA issues draft guidance on assessing container and closure systems for drugs and biologics (Published 17-Aug-2026) | Read article on RAPS.org

Sai Bhamidipati on the new era of digitizing CMC (Published 18-Aug-2026) | Read article on RAPS.org

Stakeholders call for flexibility in guidance aimed at reducing animal testing for cancer drugs (Published 18-Aug-2026) | Read article on RAPS.org

 Study highlights difficulty of measuring non-clinical factors that could influence FDA drug approval decisions (Published 18-Aug-2026)  | Read article on RAPS.org

FDA issues draft guidance clarifying differences between ANDAs and 505(b)(2) applications (Published 18-Aug-2026) | Read article on RAPS.org

Experts discusses need to modernize evidentiary models in rare diseases (Published 20-Aug-2026) | Read article on RAPS.org

FDA finalizes Q&A guidance on developing cell and gene therapies (Published 20-Aug-2026) | Read article on RAPS.org

Why documentation failures increase audit risk and weaken confidence in your quality processes (Published 24-Aug-2026) | Read article on RAPS.org

Marina Daineko on exploring femtech and other understudied populations (Published 24-Aug-2026) | Read article on RAPS.org

Therapeutic equivalence: FDA finalizes guidance on TE evaluations (Published 24-Aug-2026) | Read article on RAPS.org

FDA warns drugmakers in India, China and the US for GMP issues (Published 25-Aug-2026) | Read article on RAPS.org

FDA drafts guidance on assessing potency of immunotherapy products (Published 25-Aug-26) | Read article on RAPS.org

Pharmaceutical groups raise questions about FDAs expedited IND pilot (Published 26-Aug-26) | Read article on RAPS.org

FDA review details use of manufacturing process models in drug applications (Published 27-Aug-26) | 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.