FDA New Approvals
The FDA has approved the fifth pegfilgrastim biosimilar for the US market, Fylnetra (pegfilgrastim-pbbk), referencing Neulasta.
Learn more about Fylnetra
The FDA has approved Vtama (tapinarof) cream 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults. This approval makes Vtama cream the first and only FDA-approved steroid-free topical medication in its class.
Learn more about Vtama
FDA Labeling Changes
The FDA has approved a label extension for Evrysdi (risdiplam) to include babies aged under two months with spinal muscular atrophy (SMA). Evrysdi is now approved to treat SMA in children and adults of all ages.
Learn more about Evrysdi
FDA New Formulations
The FDA has approved the intravenous (IV) formulation of Tpoxx (tecovirimat) for the treatment of smallpox. The IV formulation is an important option for those who are unable to swallow the oral capsules of Tpoxx.
Learn more about Tpoxx
The FDA has approved Tyvaso DPI (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.
Learn more about Tyvaso DPI
FDA New Indications
The FDA has approved Beovu (brolucizumab-dbll) 6mg for the treatment of diabetic macular edema. The approval represents the second FDA-approved indication for Beovu, which was first approved for the treatment of wet age-related macular degeneration in 2019.
Learn more about Beovu
The FDA has approved Dupixent (dupilumab) 300mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40kg. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the US.
Learn more about Dupixent
The FDA has granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings.
Learn more about Kymriah
The FDA has approved both Opdivo (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 status.
Learn more about Opdivo
The FDA has approved Tibsovo (ivosidenib) in combination with azacytidine for the treatment of individuals with newly diagnosed isocitrate dehydrogenase-1-mutated acute myeloid leukemia who are aged 75 years or older or who have comorbidities that preclude the use of intensive induction of chemotherapy.
Learn more about Tibsovo
The FDA has approved Vidaza (azacytidine) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia, a rare blood cancer where certain types of white blood cells do not mature normally.
Learn more about Vidaza
Artri Ajo King Joint Supplements
Walmart Inc. is voluntarily recalling all lots of Artri Ajo King Joint Supplements sold by Innovacion Naturals and PDX Supply Warehouse LLC on Walmart.com and shipped by Walmart, to the consumer level. FDA laboratory analysis confirmed that Artri Ajo King Omega 3 Joint Support Supplement with LOTE LTARTKNGOMG30720, CADUCIDAD DICIEMBRE 2026, UPC 7 501031 111190 contains diclofenac not listed on the product label.
Learn more about the Artri Ajo King Joint Supplements recall
Teva Anagrelide Capsules
Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of anagrelide capsules, USP 0.5mg (Lot number GD01090), to the consumer level in the US. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.
Learn more about the Teva anagrelide capsules recall
Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma and follicular lymphoma.
Learn more about the Ukoniq drug safety communication