FDA New Approvals
The FDA has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 inhibitor. Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Learn more about Brenzavvy
The FDA has approved Jaypirca (pirtobrutinib) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.
Learn more about Jaypirca
The FDA has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the once-a-day treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months.
Learn more about Jesduvroq
The FDA has approved Orserdu (elacestrant) for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Learn more about Orserdu
The FDA has approved Rykindo (risperidone) extended-release injectable suspension, for intramuscular use, for treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder in adults.
Learn more about Rykindo
FDA New Indications
The FDA has approved Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. This is the fourth approved indication for Brukinsa.
Learn more about Brukinsa
The FDA has approved Keytruda (pembrolizumab) for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4cm), II, or IIIA non-small cell lung cancer (NSCLC). This approval marks the fifth indication for Keytruda-based regimens in NSCLC and the 34th indication for Keytruda in the US.
Learn more about Keytruda
The FDA has approved Revatio (sildenafil) for the treatment of pulmonary arterial hypertension (WHO Group I) in pediatric patients (age 1 to 17 years) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise.
Learn more about Revatio
The FDA has approved Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Learn more about Tukysa
FDA New Dosing
The FDA has approved Tezspire (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is the only biologic approved for severe asthma with no phenotype (eg, eosinophilic or allergic) or biomarker limitation within its approved label.
Learn more about Tezspire
Edgewell Personal Care Company Banana Boat Sunscreen
Edgewell Personal Care Company expanded its voluntary nationwide recall of three batches of Banana Boat hair and scalp sunscreen spray SPF 30, to the consumer level. One additional batch has been added to the original recall announced on July 29, 2022.
Learn more about the Edgewell Personal Care Company Banana Boat sunscreen recall
IBSA Pharma Inc. is voluntarily recalling 27 lots of Tirosint-Sol (levothyroxine sodium) oral solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company's analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.
Learn more about the Tirosint-Sol recall