Product Approvals and Launches

Patients with primary biliary cholangitis (PBC) can use linerixibat to address cholestatic pruritus, which up to 89% of patients with PBC experience.

The newly approved mosunetuzumab for relapsed/refractory follicular lymphoma improves clinic efficiency and patient experience, says Zahra Mahmoudjafari, PharmD, MBA, BCOP.

Icotrokinra is the first and only interleukin-23–targeted oral peptide approved for plaque psoriasis.

Subcutaneous mosunetuzumab simplifies the delivery of the bispecific therapy for patients with relapsed/refractory follicular lymphoma, says Zahra Mahmoudjafari, PharmD, MBA, BCOP.

Secukinumab becomes the only IL-17A inhibitor approved for this population and the first new mechanism in the indication in nearly a decade.

Beyond progression-free survival, the combination of teclistamab and daratumumab hyaluronidase-fihj showed deep clinical responses, notes Ajay K. Nooka, MD, MPH.

Phase 3 trials show deucravacitinib, the first TYK2 inhibitor approved for adults with active psoriatic arthritis (PsA), improves both joint and skin symptoms.

The FDA approved kinase inhibitors, biologics, a pancreatic cancer device, GLP-1 updates, and a new ultrarare disease pathway in February 2026.

Teclistamab had received an accelerated approval in October 2022; the combination regimen is administered subcutaneously.

This approval was based on data from the Beamion LUNG-1 trial.

Data from the phase 3 BREAKWATER trial supported full FDA approval of the encorafenib combination for metastatic CRC with a BRAF V600E mutation, demonstrating significant survival gains.

The approval, dupilumab's ninth in the US, is supported by the phase 3 LIBERTY-AFRS-AIMS trial.

FDA draft guidance outlines a new pathway to speed up approval of individualized genome and RNA therapies for rare diseases when RCTs are not feasible.

FDA approves 4-dose KwikPen for tirzepatide (Zepbound; Eli Lilly), offering a full month of weight management treatment in 1 device.

The FDA approved acalabrutinib and venetoclax, a fixed‑duration all‑oral CLL/SLL first‑line combo, based on phase 3 AMPLIFY trial data.

Today's approval enables once-monthly SC amivantamab dosing for patients with EGFR-mutant NSCLC, reducing clinic visits without compromising efficacy or safety.

The FDA granted sibeprenlimab accelerated approval for nephropathy after data showed it cut IgA nephropathy proteinuria by about 50% via APRIL inhibition.

The FDA approved Optune Pax, a first-of-its-kind portable device delivering tumor-treating fields for locally advanced pancreatic cancer treatment at home.

To protect patients, the FDA will restrict ingredients in unapproved compounded GLP‑1 drugs and crack down on misleading marketing.

Aquestive Therapeutics receives a complete response letter for dibutepinephrine (Anaphylm), a sublingual epinephrine therapy.

This approval brings the total indications for daratumumab and hyaluronidase to 5 in newly diagnosed disease and its 12th overall.

The most pressing questions in ITP involve finding a cure and developing treatments safe for use during pregnancy.

Rilzabrutinib (Wayrilz; Sanofi), a BTK inhibitor, targets immune-mediated platelet destruction in immune thrombocytopenia (ITP) and has demonstrated a favorable safety profile.

These pieces highlight several newly approved therapies that expanded treatment options across multiple disease states.

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes.

The FDA approves Wegovy, the first oral GLP-1 pill, offering a new weight loss solution for those struggling with obesity and overweight.

The FDA approved subcutaneous mosunetuzumab for relapsed follicular lymphoma, providing a more convenient outpatient option.

The cardiac myosin inhibitor is expected to be available in the US in the second half of January 2026.