FDA Approves Sorilux (Calcipotriene) for Adolescent Plaque Psoriasis
Vitamin D analog foam indicated for topical treatment of plaque psoriasis in teens.
New Corlanor (Ivabradine) Formulation Approved by FDA
Oral solution now approved for adults and pediatric patients.
Generic VESIcare Tablets to Launch in U.S.
Update: now available from three manufacturers.
FDA Approves Nayzilam (Midazolam) for Seizure Activity in Patients with Epilepsy
Nayzilam is a benzodiazepine antiepileptic nasal spray.
FDA Approves Fragmin as First Pediatric Anticoagulant Treatment
Fragmin, a low-molecular-weight heparin dalteparin sodium injection, was approved for symptomatic venous thromboembolism.
FDA Approves Expanded Indication for Venetoclax
Venetoclax, a BCL-2 inhibitor first approved in 2016, is now indicated for chronic lymphocytic leukemia and small lymphocytic lymphoma.
Bavencio (Avelumab), Inlyta (Axitinib) Combination Approved for Advanced Renal Cell Carcinoma by FDA
Approval marks the first anti-PD-L1 therapy combination for RCC.
Ruzurgi (Amifampridine) Approved for Rare Pediatric Autoimmune Disorder
Ruzurgi approval for rare autoimmune disorder may be an olive branch.
Kadcyla Indication Expands as Adjuvant Breast Cancer Treatment
Recent trial shows greater invasive disease-free survival when treated with Kadcyla , (ado-trastuzumab emtansine)
Qternmet XR Combinations Approved for Type-2 Diabetes
New drug combines dapagliflozin, saxagliptin, and metformin.
Two Drugs Approved for Cardiomyopathy Caused by Amyloidosis
Two different versions of tafamadis get the FDA’s nod to treat a rare heart disease.
Tibsovo Indication Expanded to Newly-Diagnosed Acute Myeloid Leukemia by FDA
Tibsovo (ivosidenib) is an isocitrate dehydrogenase1- inhibitor, originally approved in 2018.
Dengvaxia Approved by FDA for Prevention of Dengue Disease
First vaccine approved for all four Dengue virus serotypes in children and teens ages 9 through 16, but comes with major restrictions and controversy.
Victoza (Liraglutide): Potential New Treatment for Child and Adolescent Type 2 Diabetes
Results from a recent ELLIPSE trial indicate superiority in reducing blood sugar when compared to the placebo.
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.
