FDA Updates

These aflibercept biosimilars are used to treat wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

Check out important updates from the FDA for the week of May 13.

Amgen’s Tarlatamab-dlle (Imdelltra) is the first and only approved DLL3-targeting bispecific T-cell engager therapy for the aggressive form of lung cancer.

Dynavax plans to meet with the FDA to discuss how the company can provide additional data to support the approval of its 4-dose Heplisav-B regimen and expand protection for adults with end-stage renal disease (ESRD) on hemodialysis.

Altuviiio was first granted approval by the FDA in February 2023.

Check out important updates from the FDA for the week of May 6.

WGc-043 is the first and only vaccine approved for this use.

The federal agency said the delay was due to administrative constraints and did not cite any vaccine safety, efficacy or quality issues.

Last August, zuranolone (Zurzuvae) became the first FDA-approved pill to treat postpartum depression in adults.

Mycophenolate mofetil oral suspension is the only FDA-approved ready-to-use liquid formulation.

Check out important updates from the FDA for the week of April 29.

According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”

Pemivibart will act as an additional preventive option for COVID-19 among moderately-to-severely immunocompromised adult and adolescent patients, who are disproportionally impacted by the condition.

Check out these important FDA updates from the month of April 2024.

WHIM syndrome is characterized by low levels of neutrophils and lymphocytes in the blood due to dysfunction in the CXCR4 receptor, which results in serious and frequent infections.

The ADORING 3 phase 3 development program is currently studying the novel, aryl hydrocarbon receptor agonist as a once-daily, cosmetically elegant, and steroid-free topical cream for adults and children with atopic dermatitis.

Check out important updates from the FDA for the week of April 22.

Fidanacogene elaparvovec-dzkt (Beqvez) is a 1 time treatment that allows patients with hemophilia B to produce factor IX themselves.

Amneal Pharmaceuticals said its generic naloxone hydrochloride nasal spray is now available in the US following FDA approval.

The approval for tovorafenib (Ojemda) was based on data from the phase 2 FIREFLY-1 trial, in which the therapy demonstrated an overall repose rate of 67%.

Abeona Therapeutics’ pz-cel is an investigational autologous, COL7A1 gene-corrected epidermal sheet therapy for the treatment of recessive dystrophic epidermolysis bullosa.

Check out important updates from the FDA for the week of April 15.

This approval is the second biosimilar approval for manufacturer Alvotech.

The company’s investigational ABCWY vaccine candidate will be reviewed by the FDA by February 14, 2025.

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Fasenra was initially approved in 2017 as an add on maintenance therapy in patients aged 12 years and older.

The antibiotic was approved to treat Staphylococcus aureas bacteremia, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.

The drug was previously approved in 2009 to treat schizophrenia.