Product Approvals and Launches

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.

The approval was based on the pivotal phase 3 FIBRONEER-ILD trial, in which nerandomilast slowed lung function decline in PPF and had similar discontinuation rates to placebo.

The approval of subcutaneous amivantamab can offer a more accessible means of treatment for patients with non–small cell lung cancer (NSCLC).

The FDA approved subcutaneous amivantamab with recombinant human hyaluronidase for EGFR-mutated NSCLC based on the phase 3 PALOMA-3 trial.

Rucaparib’s full approval for BRCA-mutated mCRPC is supported by data showing significant gains in radiographic progression-free survival.

Twice-yearly depemokimab cuts asthma exacerbations in phase 3 trials for patients aged 12 and older with severe eosinophilic asthma.

Intranasal etripamil was approved to self-treat episodes of paroxysmal supraventricular tachycardia, supported by phase 3 RAPID trial data.

Today, the FDA issued new guidance allowing de-identified real-world evidence in certain medical device applications, removing a barrier to using large data sources.

The FDA approved trastuzumab deruxtecan plus pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed major PFS gains.

Lerodalcibep-liga subcutaneous injection is now approved for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

Inebilizumab gains FDA approval for treating generalized myasthenia gravis, showing significant improvements in muscle strength and steroid reduction.

Five key oncology FDA approvals came through last month, expanding treatment options across multiple cancer types.

As the first immunotherapy option in this setting, the approval sets a new standard for resectable early-stage gastric and gastroesophageal junction (GEJ) cancers.

Pirtobrutinib is now fully approved for CLL/SLL in those previously treated with Bruton tyrosine kinase inhibitors.

Peter Voorhees, MD, explains how daratumumab and hyaluronidase-fihj show superior efficacy in delaying progression of MM compared with active monitoring.

Sibeprenlimab gains accelerated approval from the FDA for IgA nephropathy, showing significant proteinuria reduction and offering convenient self-injection treatment.

This approval makes durvalumab with FLOT chemotherapy the first perioperative immunotherapy for resectable gastric or gastroesophageal junction adenocarcinoma.

Onasemnogene abeparvovec-brve is now the first gene replacement therapy approved for spinal muscular atrophy in patients 2 years and older.

The FDA expanded approvals for key medications, enhancing treatment options for atopic dermatitis, inflammatory bowel disease, type 2 diabetes, and more.

The FDA has approved pembrolizumab and enfortumab vedotin for muscle-invasive bladder cancer (MIBC), offering new hope for patients ineligible for cisplatin.

The FDA approved selumetinib for adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas based on the KOMET trial.

The accelerated approval was based on a study that evaluated the efficacy in unresectable or metastatic nonsquamous NSCLC.