A biologics license application for Ryoncil (remestemcel-L), submitted by Mesoblast, Inc, for the proposed use to treat steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients. Ryoncil consists of a suspension of ex-vivo culture-expanded adult human mesenchymal stromal cells for intravenous infusion.

Pediatric development plans for the following 4 drug candidates in clinical development: (1) SP 2577, by Salarius Pharmaceuticals, Inc.; (2) Marizomib, by Celgene International II Sàrl, a wholly owned subsidiary of Bristol-Myers Squibb; (3) CD30.CAR-T, by Tessa Therapeutics; and (4) SNDX-5613, by Syndax Pharmaceuticals, Inc.

Overview and updates of research programs in the Tumor Vaccines and Biotechnology Branch (TVBB) and Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), CBER, FDA

Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)

1) Padeliporfin di-potassium, by STEBA Biotech, S.A., proposed for certain patients with localized prostate cancer

2) CYRAMZA (ramucirumab), by Eli Lilly and Company, proposed for certain patients with metastatic non-small cell lung cancer

New drug application (NDA) resubmission for bupivacaine extended-release solution for instillation (Proposed US trade name: POSIMIR), submitted by DURECT Corp. (Durect), for the proposed indication of post-surgical analgesia

Morning session: NDA for E-58425, by Esteve Pharmaceuticals, S.A. (Esteve), proposed for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Afternoon session: NDA for an extended-release oral tablet formulation of oxycodone (proposed US trade name: Aximris XR), submitted by Intellipharmaceutics Corp. (Intellipharmaceutics), proposed for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

Oxycodegol, submitted by Nektar Therapeutics, proposed for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Vernakalant HCl solution for intravenous injection (Proposed US Trade Name: Brinavess), resubmitted by Correvio International Sàrl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: atrial fibrillation ≤ 7 days duration, and for post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration

Supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

Supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc. (Amarin), for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease

1) ) Overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA

2) Recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season

1) Pediatric-focused safety review of OxyContin (oxycodone)

2) Considerations for opioid analgesic pediatric studies and labeling

Pediatric-focused safety review of neuropsychiatric events with use of Singulair (montelukast)

A new drug application (NDA) by GlaxoSmithKline Consumer Healthcare Holdings for over-the-counter nicotine oral spray

Biologics license application (BLA) for Peanut [Arachis hypogaea] Allergen Powder manufactured by Aimmune Therapeutics, Inc, indicated for treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy

Supplemental new drug application (sNDA) for DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV