FDA Bursts

In cooperation with the Food and Drug Administration (FDA), and as a service to our members, we will periodically distribute information about newly approved therapies or significant changes to approved therapies. This helps FDA to inform professionals in patient care arena of recent approvals in a timely manner. Included in the email from the FDA is a link to the product label, which will provide the relevant clinical pharmacology information on the indication, contraindications, dosing, and safety. In sending this information, we do not endorse any product or therapy and do not take any position on the safety or efficacy of the product or therapy described.

FDA Approves ILUMYA for Adult Plaque Psoriasis

FDA Approves TROGARZO (ibalizumab-uiyk)

FDA Announces Availability of the Guidance, “E18 Genomic Sampling and Management of Genomic Data”

FDA Approves BIKTARVY (bictegravir, embitcitabine, tenofovir alafenamide) for HIV-1 Infection in Adults Who Have No Antiretroviral Treatment History or to Replace Current Antiretroviral Regimen in Those Who Are Virologically Suppressed

FDA Announces Draft Guidance Labeling for Combined Hormonal Contraceptives

FDA Announces Draft Guidance Low Frequency Molecular Subsets

FDA Approves PREVYMIS (Letermovir)

FDA Approves CALQUENCE (Acalabrutinib) 

FDA Announces Availability of Two Draft Guidances

FDA Approves Tracleer® (Bosentan) 

FDA Approves VABOMERE™ (Meropenem and Vaborbactam) 

FDA Approves BESPONSA (Inotuzumab Ozogamicin)

FDA Uses Extrapolation to Expand FYCOMPA® (Perampanel)

FDA Approves MAVYRET (Glecaprevir and Pibrentasvir)

FDA Approves VYXEOS® (Daunorubicin and Cytarabine)

FDA Approves VOSEVI (Sofosbuvir, Velpatasvir, and Voxilaprevir)

FDA Approves RITUXAN HYCELA™ (Rituximab and Hyaluronidase)

FDA Approves IDHIFA® (Enasidenib)

FDA Issues Highlights of Prescribing Information for BAXDELA

FDA Approves Gleolan [aminolevulinic acid hydrochloride (ALA HCl)] 

FDA Expands Kalydeco (Ivacaftor)

FDA Approves IMFINZI (Durvalumab) 

FDA Approves 
RYDAPT® (Midostaurin)

FDA Approves DUPIXENT (Dupilumab)

FDA Approves OCREVUS (Ocrelizumab)

FDA Approves ALUNBRIG (Brigatinib)

FDA Approves ZEJULA (niraparib)

FDA Approves BAVENCIO (avelumab)

FDA Approves KISQALI(ribociclib)


FDA Announces Availability of the Guidance, "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product" 


FDA Announces Availability of the Draft Guidance,"Physiologically Based Pharmacokinetic Analyses-Format and Content"

2016 FDA Bursts