Janssen's sirukumab injection (proposed trade name PLIVENSIA) for certain patients with rheumatoid arthritis
Read MoreJUL 28 VRBPAC
HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] by Dynavax Technologies Corp.
Read MoreJUL 13 ODAC
Morning session: proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. Afternoon session: a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH.
Read MoreJUL 12 ODAC
Tisagenlecleucel-T suspension by Novartis Pharmaceuticals Corp. for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)
Read MoreJUL 11 ODAC
Mylotarg (gemtuzumab ozogamicin) by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. for use is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML)
Read MoreJUN 26 SBFDA
1) FDA's biotechnology activities related to plant-derived food and animals
2) Report from the National Antibiotic Resistance Monitoring System Review Subcommittee
Read MoreJUN 21-22 ODAC
Potential pediatric development plans/written requests for: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company; and (5) Olaratumab, presentation by Eli Lilly and Company.
Read MoreJUN 20 EMDAC
Novo Nordisk VICTOZA (liraglutide) for the proposed additional indication as an adjunct to standard treatment of cardiovascular risk factors
Read MoreMAY 25 ODAC
Proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company
Read MoreMAY 24 ODAC
1) Puma Biotechnology’s neratinib for HER2 breast cancer 2) Emmaus Medical, Inc’s glutamine solution for sickle cell disease
Read MoreMAY 18 PEDAC
Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”
Read MoreMAY 10 MIDAC
5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery
Read MoreMAY 9 SBFDA
Recommendations on the Agency’s Innovation Funds work plan as prescribed in section 1002 of the 21st Century Cures Act
Read MoreMay 17 VRBPAC
Considerations for evaluation of Respiratory Syncytial Virus vaccines in seronegative infants
Read MoreMAY 8-9 PCAC
Review of substances nominated for the list of bulk substances allowed for compounding and products nominated for the difficult to compound list
Read MoreAPR 13 AMDAC
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
Read MoreAPR 4-5 BPAC
1) Recombinant Human Coagulation Factor IX, GlycoPEGylated 2) Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products 3) Research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases
Read MoreAPR 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read MoreMAR 29 ODAC
Rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc.
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