Product Approvals and Launches

The Shield blood test developed by Guardant has been approved by the FDA as a primary screening option for colorectal cancer, providing a more convenient method of screening.

The FDA has approved deuruxolitinib, an oral medication developed by Sun Pharma, as the first-line treatment for adults with moderate to severe alopecia areata.

“It's nice to have another option that we can discuss with patients,” said Yasmin H. Karimi, MD, University of Michigan, about epcoritamab’s label expansion for difficult-to-treat relapsed/refractory (R/R) follicular lymphoma.

The catheter-delivered implant uses the right ventricle to support the left, improving left ventricle ejection fraction and helping restore the heart’s normal shape.

The aflibercept 8 mg injection improves patient care by allowing longer intervals between treatments, explains Jose A. Martinez, MD, Austin Retina Associates.

Today, the FDA approved roflumilast cream 0.15% (Zorvye; Arcutis Biotherapeutics) for the treatment of mild to moderate atopic dermatitis in patients 6 years and older.

FoundationOne Liquid CDx can be used to identify niraparib and abiraterone acetate eligibility in patients with metastatic castration-resistant prostate cancer (mCRPC).

Donanemab-azbt is the first and only amyloid plaque-targeting therapy approved for adults with early symptomatic Alzheimer disease.

The FDA approved SH-105 (Tepylute) prediluted injectable treatment for breast and ovarian cancers. This innovative formulation eliminates the need for complex powder reconstitution, improving safety and patient care.

Today, the FDA approved ensifentrine (Ohtuvayre; Verona Pharma) for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) based on the successful phase 3 ENHANCE trials.

The FDA today approved efgartigimod alfa and hyaluronidase-qvfc for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Adult patients who have KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) can use adagrasib as a supplemental treatment.

Accelerated approval was originally granted in June 2023 for patients aged 4 to 5 years, indicating there was an unmet clinical need for a potentially life-saving treatment for the rare genetic muscle disorder.

The FDA approved pembrolizumab (Keytruda) plus carboplatin and paclitaxel, followed by single-agent pembrolizumab, in adult patients with primary advanced or recurrent endometrial carcinoma.

The FDA has approved durvalumab combined with carboplatin and paclitaxel, followed by single-agent durvalumab.

Bringing the bispecific T-cell engager into the frontline consolidation phase "redefines the standard of care" for patients with B-ALL, an investigator said.

Neurotrophic tyrosine receptor kinase (NTRK)–positive locally advanced or metastatic solid tumors can now be treated with the first FDA-approved treatment option.

Children aged 10 years and older with type 2 diabetes can now improve their glycemic control with a drug previously only approved for adults.

The approval brings a new treatment option to pediatric patients with polyarticular juvenile idiopathic arthritis, which is a form of arthritis affecting multiple joints at the same time.

The latest approval of lisocabtagene maraleucel (liso-cel) in mantle cell lymphoma provides another treatment option and continues the tremendous advances in treatment for patients, said Christopher Flowers, MD, of MD Anderson Cancer Center.

The FDA approved mRNA-1345, a Moderna vaccine for the treatment of respiratory syncytial virus (RSV). This single-dose vaccine offers protection against lower respiratory tract disease in adults over 60 years, with data suggesting long-term effectiveness.

Mantle cell lymphoma is the fourth subtype of non-Hodgkin lymphoma that can be treated with this CAR T-cell therapy.

In the final part of our interview with Binod Dhakal, MD, lead investigator of the CARTITUDE-4 study, he looks to the future of earlier treatment for relapsed/refractory multiple myeloma.

The approval makes belimumab (Benlysta) the first at-home treatment in its class for patients 5 years and older with systemic lupus erythematosus (SLE).

Vamorolone (Agamree) is a first-in-class corticosteroid to treat Duchenne muscular dystrophy (DMD) in patients 2 years and older.

The FDA approved the first 2 biosimilars referencing aflibercept (Eylea). However, patent litigation has left it unclear when the biosimilars will come to market.

Amy Shapiro, MD, medical director, Indiana Hemophilia and Thrombosis Center, continues her discussion on plasminogen deficiency type 1 by highlighting the recent FDA approval of plasminogen (Ryplazim; Kedrion Biopharma), the first treatment specifically indicated for this disorder.

The FDA has approved tarlatamab (Imdelltra; Amgen), a novel bispecific T-cell engager, to treat patients with extensive-stage small cell lung cancer (SCLC).