Product Approvals and Launches

Patients with endocrine-resistant, HER2-negative, locally advanced or metastatic breast cancer can use the treatment after recurrence or completing adjuvant endocrine therapy.

The approval came days before the FDA’s expected deadline and makes this the only PD-1 inhibitor approved for resectable non–small cell lung cancer (NSCLC) in the neoadjuvant and adjuvant settings.

Surbhi Sidana, MD, MBBS, shares how the addition of an anti-CD38 antibody to the VRd regimen significantly improves progression-free survival for patients with transplant-ineligible multiple myeloma.

On September 20, the FDA approved isatuximab plus bortezomib, lenalidomide, and dexamethasone in the first line for patients who have multiple myeloma and are ineligible for transplant.

In less than a month, from August 20 to September 19, amivantamab (Ami; Rybrevant, Johnson & Johnson) received 2 approvals from the FDA for use in non–small cell lung cancer (NSCLC).

On September 19, the FDA handed down its third amivantamab (Rybrevant; Johnson & Johnson) approval for 2024 in non–small cell lung cancer (NSCLC), giving the third-generation tyrosine kinase inhibitor its fourth approval overall.

Formally known as KarXT, xanomeline-trospium chloride (Cobenfy) receives approval from the FDA for the treatment of schizophrenia in adults.

The approval means an additional indication for osimertinib (Tagrisso; AstraZeneca) for adult patients who have unresectable stage III non–small cell lung cancer (NSCLC) with EGFR mutation.

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.

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.