Product Approvals and Launches

The FDA has approved FluMist (AstraZeneca) for self-administration by adults up to age 49 years or for caregiver administration for children aged 2 to 17 years, making it the first self-administered flu vaccine option.

Bimekizumab-bkzx (Bimzelx) is now FDA approved for 4 chronic immune-mediated inflammatory diseases: psoriatic arthritis, nonradiographic axial spondyloarthritis (axSpA), ankylosing spondylitis, and moderate to severe plaque psoriasis.

Isatuximab (Sarclisa) with bortezomib, lenalidomide, and dexamethasone (VRd) is now an approved option for adults who cannot receive an autologous stem cell transplant to treat their newly diagnosed multiple myeloma.

The FDA approval of amivantamab-vmjw (Rybrevant) in combination with chemotherapy is the first targeted treatment to cut disease progression risk for EGFR-positive non–small cell lung cancer (NSCLC).

The FDA approved benralizumab (Fasenra) for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

The FDA approved ribociclib (Kisqali) for adjuvant treatment of high-risk, hormone receptor-positive, HER2-negative early breast cancer.

Ocrelizumab and hyaluronidase is now the first and only twice-yearly subcutaneous injection approved for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

Alzheimer disease research is yielding breakthroughs with blood tests and brain scans that can enhance early diagnosis, while new drugs promise to slow the disease and improve patients’ lives.

This newest approval for amivantamab is the second approval in 6 months for the EGFR and MET bispecific antibody.

The expanded approval for the Omnipod 5 system now allows automated insulin delivery (AID) for adults with type 2 diabetes, offering a new option for better glucose management without daily injections.

The complete response letter (CRL) was issued based on a pre-approval inspection at a third-party fill/finish manufacturer.

The FDA's decision to reject midomafetamine (MDMA) capsules in combination with assisted psychotherapy (MDMA-AT) for adults with PTSD reignited the controversial conversation around investigative psychedelic therapy.

Patients with non-small cell lung cancer (NSCLC) can use lazertinib in combination with amivantamab as a first-line treatment.

CDC data from 2021 show the lifetime cost of treating syphilis to be $1190.

Along with the company reorganization, Lykos announced it will be reducing its workforce by approximately 75%, with the remaining team focused on continuing efforts in clinical development, medical affairs, and engagement with the FDA.

The newly approved treatment regimen demonstrated a significant reduction in recurrence risk in patients with resectable non–small cell lung cancer (NSCLC).

The FDA has approved axatilimab-csfr (Niktimvo) for treating adults and children with chronic graft-versus-host disease who have progressed on at least 2 prior treatments.

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

Today, the FDA issued a complete response letter (CRL) for midomafetamine capsules (MDMA) in combination with assisted therapy (MDMA-AT) for adults living with posttraumatic stress disorder (PTSD).

Arash Mostaghimi, MD, MPA, MPH, assistant professor of dermatology, director of the inpatient dermatology consult service, and codirector of the Complex Medical Dermatology Fellowship at Brigham & Women's Hospital, discusses the recent FDA approval of deuruxolitinib for the treatment of moderate to severe alopecia areata.

Vorasidenib becomes the first targeted therapy for grade 2 isocitrate dehydrogenase (IDH)–mutant glioma to receive FDA approval.

Afami-cel, sold as Tecelra by Adaptimmune, is the first gene therapy to be approved for the rare form of cancer and the first FDA-approved T-cell receptor gene therapy.

Daratumumab/hyaluronidase-fihj plus bortezomib, lenalidomide, and dexamethasone is now approved by the FDA to treat newly diagnosed multiple myeloma (MM) in patients eligible for autologous stem cell transplant.

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).