Benlysta (belimumab) Indication Expanded to Children with Systemic Lupus Erythematosus (SLE)
Benlysta is the first approved treatment for children with lupus.
Eticovo (etanercept-ykro) Approved for Arthritis, Spondylitis, and Plaque Psoriasis
Eticovo (etanercept-ykro) is a TNF blocker, biosimilar to Enbrel (etanercept).
Duobrii (halobetasol propionate and tazarotene) Moisturizing Lotion for Plaque Psoriasis
New lotion from Ortho Dermatologics expected June 2019.
FDA Approves New COPD Maintenance Treatment
DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) provides LAMA/LABA therapy.
US Bioservices will Dispense Diacomit in Exclusive Deal
Diacomit (stiripentol) is indicated for rare, severe form of pediatric epilepsy.
AbbVie’s Risankizumab-rzaa Granted Regulatory Approval
Indicated for adults with moderate to severe plaque psoriasis.
Spravato for Treatment-Resistant Severe Depression (Update)
Esketamine comes with close supervision requirements. 800 clinics have already been approved and dispensed initial applications.
First Narcan Generic Gains Regulatory Approval
FDA granted final approval to drug originally tentatively approved in 2018.
Keytruda (Pembrolizumab) Issued New Dosage and Indication
The FDA has recently approved new dosage form and two new indications for the drug.
Balversa Fast-Tracked for Bladder Cancer
Erdafitinib is first targeted therapy for FGFR3 or FGFR2 genetic alteration.
Flibanserin (Addyi) Issued Label Change
Safety alert issued requiring warning about concurrent alcohol use.
FDA Approves Evenity for Osteoporosis
Evenity (romosozumab-aqqg) has been approved to treat postmenopausal women at high risk of bone fractures.
Soltamox (Tamoxifen Citrate) Issued Labeling Change
Women no longer require nine months of contraception post cessation of the drug.
DOVATO (Dolutegravir and Lamivudine) Approved for HIV-1
First-ever dual-drug, single tablet for HIV offers lighter treatment regimen.
Breast Cancer Drug Gains Approval for Males
Sunosi (Solriamfetol) Approved for Excessive Daytime Sleepiness in Adults
Solriamfetol is approved for adult patients suffering from the effects of narcolepsy and OSA.
Mayzent (Siponimod) Granted FDA Approval for SPMS
The next-generation oral drug is the first to be approved specifically for secondary progressive multiple sclerosis in more than 15 years.
Zulresso Approved for Postpartum Depression in Adult Women
First drug approved for PPD use to remain under REMS program.
FDA Approves Generic for Diovan
Ongoing valsartan shortages due to recalls prompt FDA prioritization.
Trazimera, Herceptin Biosimilar, Gains FDA Approval
Indicated for breast cancer, and gastric or gastroesophageal junction adenocarcinoma.
Lower-Priced Insulin Coming Soon
Eli Lilly creates generic Humalog priced 50% lower
AllianceRx Walgreens Prime to Distribute Probuphine Implants
Restricted implants indicated for maintenance of opioid dependency.
New Drug Review: Dsuvia (Sufentanil) for Acute Refractory Pain
Sublingual form approved for short-term use.
Medtronic plc Granted Breakthrough Device Clearance for PCL Insulin Pump
The new device will increase real-time personalization and predictive diagnostics for patients.
EGATEN for Treatment of Fascioliasis
Anthelmintic tablet for patients 6 years of age and older.
Cablivi for Acquired Thrombotic Thrombocytopenic purpura
What you need to know about the von Willebrand factor (vWF)-directed antibody fragment.
Jeuveau (PrabotulinumtoxinA-xvfs) for Glabellar Lines
What you need to know about the new botulinum toxin product.
Generic Tolterodine Tartrate ER Capsules for Overactive Bladder
Ultomiris for Paroxysmal Nocturnal Hemoglobinuria
Elzonris for Blastic Plasmacytoid Dendritic Cell Neoplasm
