Heritable Disorders in Newborns and Children
Read MoreAUG 3 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
Read MoreAUG 2 AAC
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 25-26 SACHRP
Topics related to human research protections
Read MoreJUL 26 AADPAC-DSRM
Intellipharmaceutics Corp.'s, oxycodone hydrochloride extended-release oral tablets
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
Commissioner and Chief Scientist Updates / FDA's biotechnology activities related to plant-derived food and animals / 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 25-26 SACHRP
1) Common Rule 2) Real-world evidence for devices
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 17 VRBPAC
Considerations for evaluation of Respiratory Syncytial Virus vaccines in seronegative infants
Read MoreMay 11-12 ACHDNC
Topics Related to Newborn Screening and Medical Foods
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
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