On Friday April 12, 2024, the Oncologic Drugs Advisory Committee (ODAC) will discuss the use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials, including considerations regarding timing of assessment, patient populations, and trial design for future studies that intend to use MRD to support accelerated approval of a new product or a new indication.

On Friday March 15, 2024, the Oncology Drug Advisory Committee (ODAC) will discuss supplemental biologics license application (sBLA) 125746.74 for CARVYKTI (ciltacabtagene autoleucel), suspension for intravenous infusion, submitted by Janssen Biotech for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide. The Committee will have a general discussion focused on the overall survival data in the Study MMY3002 (CARTITUDE-4) and the risk and benefit of ciltacabtagene autoleucel in the intended population.
During the afternoon session, the Committee will discuss sBLA 125736.218 for ABECMA (idecabtagene vicleucel), suspension for intravenous infusion, submitted by Celgene Corp., a Bristol-Myers Squibb Co. The proposed indication is for the treatment of adult patients with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The Committee will have a general discussion focused on the overall survival data in the Study MM-003 (KarMMa-3) and the risk and benefit of idecabtagene vicleucel in the intended population.

On Thursday 14 March 2024, the Oncology Drug Advisory Committee (ODAC) will discuss new drug application (NDA) 217779 for Imetelstat for injection, submitted by Geron Corporation for the proposed indication for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents.

On March 5, 2024, the Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season.

On Tuesday, March 5, 2024, the Medical Imaging Drugs Advisory Committee will discuss efficacy and safety data submitted by submitted by Lumicell in support of a new drug application (NDA) 214511 for pegulicianine for injection. The proposed indication for pegulicianine is for use in patients with breast cancer to assist in the detection of cancerous tissue within the lumpectomy cavity following removal of the primary specimen during lumpectomy surgery.

The USFDA has scheduled a Pulmonary-Allergy Drug Advisory Committee
[PADAC] on November 17, 2023, to discuss a new drug application (NDA-215010), for gefapixant oral tablets, submitted by Merck Sharp & Dohme Corp., for the proposed indication of treatment of adults with refractory or unexplained chronic cough.

On November 16, 2023, the Oncology Drug Advisory Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not met their agreed-upon milestones for completion of confirmatory trial(s). These updates will provide information on the status of all accelerated approvals granted in oncology, including products with delayed confirmatory trials, and the status of confirmatory trials for the specific NDAs to be discussed, including any ongoing and planned trials.

The USFDA has scheduled a Cellular, Tissue, and Gene Therapies Advisory Committee
[CTGTAC] on October 31, 2023, to discuss and make recommendations on biologics license application (BLA) 125787 from Vertex Pharmaceutical’s Inc. Exagamglogene autotemcel (exa-cel) for the treatment of Sickle cell disease (SCD) in patients 12 years and older with Recurrent Vaso-occlusive crises (VOCs).

The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee [VRBPAC] meeting for October 5, 2023. During the meeting, the committee will discuss the Strain Selection for the Influenza Virus Vaccines for the 2024 Southern Hemisphere Influenza Season.

On October 4th 2023, the Oncologic Drugs Advisory Committee [ODAC] will discuss new drug application (NDA) 215500, for eflornithine tablets, submitted by USWM, LLC. The proposed indication (use) for this product is to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma who have completed multiagent, multimodality therapy.

The USFDA has scheduled a Cellular, Tissue, and Gene Therapies Advisory Committee
[CTGTAC] on September 27, 2023, to discuss and make recommendations on biologics license application (BLA) 125782 from BrainStorm Therapeutics, Inc. for debamestrocel NurOwn® (autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors (MSC-NTF). BrainStorm Therapeutics has requested an indication for the treatment of amyotrophic lateral sclerosis (ALS).

On Thursday, Sept 21, 2023, the Endocrinologic Drugs Advisory Committee (EDAC) will discuss the safety and efficacy of ITCA 650 (exenatide in DUROS device), a drug-device combination product that is the subject of a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia) (NDA 209053), for the proposed indication, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.

The USFDA has scheduled a Cardiovascular and Renal Drugs [CRDAC] Advisory Committee Meeting for September 13, 2023, to discuss a supplemental new drug application (sNDA- 210922-s015), for ONPATTRO (patisiran) lipid complex for injection, submitted by Alnylam Pharmaceuticals, Inc., for the proposed treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults.

On Wednesday, June 28, 2023, the Endocrinologic Drugs Advisory Committee will discuss new drug application (NDA-215559), for Palovarotene capsules, submitted by Ipsen Biopharmaceuticals, Inc. The proposed indication is the prevention of heterotopic ossification in adults and children (females aged 8 years and above and males 10 years and above) with fibrodysplasia ossificans progressive (FOP).

The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on June 15th 2023, to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024.

On Friday, June 9th, 2023, the Peripheral and Central Nervous System Drugs Advisory Committee ([PCNS]) will discuss supplemental biologics license application (sBLA-761269/s-001), for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of disease. The committee will also discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement.

The Antimicrobial Drugs Advisory Committee (AMDAC) has scheduled a meeting on Thursday June 08, 2023, through an online teleconferencing platform. During the meeting, the committee will discuss  biologics license application (BLA 761328), for Nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use, submitted by AstraZeneca. The proposed indication is prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

The USFDA has scheduled a Gastrointestinal Drugs Advisory Committee (GIDAC) meeting on Friday, May 18, 2023. The committee will meet to discuss new drug application (NDA- 212833) for Obeticholic acid (OCA) 25 mg oral tablets, submitted by Intercept Pharmaceuticals, Inc., for the treatment of pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.

The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Thursday May 18, 2023. The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), submitted by Pfizer, with a requested indication, in Biologics License Application (BLA-125768) STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.

The Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) has scheduled a meeting on Friday May 12, 2023. During the meeting, the committee will review Biologic license application (BLA 125781) submitted by Sarepta Therapeutics, Inc. for delandistrogene moxeparvovec with the requested indication for the treatment of ambulatory patients with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene.

On 9th and 10th May 2023, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will discuss sNDA for OPILL (norgestrel) tablet, submitted by Laboratoire HRA Pharma for nonprescription use to prevent Pregnancy.

On Friday, April 28, 2023, the Oncologic Drugs Advisory Committee (ODAC) will discuss a supplemental new drug application (sNDA 208558/S–025), for LYNPARZA (Olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with Metastatic castration-resistant prostate cancer (mCRPC).

On Wednesday, April 26, 2023, the Blood Products Advisory Committee (BPAC) will meet in open session to hear an overview of the research programs in the Division of Hemostasis, Office of Plasma Protein Therapeutics Chemistry, Manufacturing, and Controls, Office of Therapeutic Products, Center for Biologics Evaluation and Research.

The AMDAC committee will discuss new drug application (NDA-216974) for sulbactam-durlobactam injection, submitted by Entasis Therapeutics for the proposed treatment of hospital‐acquired bacterial pneumonia (HABP) and ventilator‐associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii‐calcoaceticus complex (ABC) in adults.

The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Peripheral and Central Nervous System Drugs Advisory Committee (PDAC) of the USFDA has scheduled a meeting on Friday, April 14th, 2023. During the meeting, the committee will discuss supplemental new drug application (sNDA 205422 s009), efficacy supplement for REXULTI (Brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer’s dementia.

On Wednesday, March 22, 2023, the PCNS advisory committee will discuss an NDA -215887, for tofersen (BIIB067) intrathecal injection, submitted by Biogen for the treatment of ALS associated with a mutation in the superoxide dismutase 1 gene.

On Thursday, Mar 16, 2023, AMDAC will discuss NDA -217188 for PAXLOVID tablets submitted by Pfizer for the proposed indication of treatment of mild-to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

On Thursday, March 9, 2023, the ODAC will discuss sBLA for POLIVY (polatuzumab vedotin-piiq) injection submitted by Genentech for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated DLBCL.

On March 7, 2023, the VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2023--2024 influenza season. 

The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Wednesday March 1, 2023. The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of AREXVY (Respiratory Syncytial Virus Vaccine, Recombinant, Adjuvanted), manufactured by GSK, with a requested indication, in BLA 125775 (STN 125775/0), for active immunization for the prevention of LRTD caused by respiratory syncytial virus RSV-A and RSV-B subtypes in adults 60 years of age and older.