SPOTLIGHT -
Biocon Launches Biosimilar Semglee
Branded and unbranded versions of the interchangeable biosimilar to treat patients with diabetes are now available.
SterRx Recalls 240 Lots of 12 Products
Equipment and process issues could lead to a lack of sterility.
Ocular Therapeutix Ophthalmic Inserts Gain Ocular Itching Indication
Inserts replace steroid eyedrops.
FDA is Recalling One Lot of Firvanq
The lot contains kits with the incorrect solution for diluting vancomycin, which could lead to doses above or below recommended levels.
Teligent Recalls One Lot of Lidocaine
The product is considered “super potent” with a higher dose that could result in serious cardiac toxicities.
Genentech Withdraws Tecentriq Approval for Metastatic Breast Cancer
Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.
FDA Approves Tibsovo for Rare, Aggressive Cancer
Tibsovo is the first targeted therapy for IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside the liver.
FDA Approves Long-Acting Growth Hormone
Developed by Ascendis Pharma, this is the first therapy that delivers growth hormone over one week.
New Dosing Options are Available for Tirosint-SOL
The liquid therapy to treat hypothyroidism now comes in 15 different dosage strengths in single-use packaging.
FDA Safety Alert: Pepaxto is Associated with Increased Risk of Death
The agency has stopped enrollment in all ongoing trials.
NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines
The June 30 approval meets an unmet need in this cancer.
Plaque Psoriasis Treatment is Launched
Wynzora is a cream-based, fixed dose combination of calcipotriene and betamethasone for topical treatment of psoriasis.
UnitedHealth Will Wait on CMS Before Setting Coverage Policy on Aduhelm
Several large payers are waiting on results from the National Coverage Determination.