FDA Updates

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

The Psychopharmacologic Drugs Advisory Committee will meet June 4 to review a new drug application from Lykos Therapeutics.

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.

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.

Rejoyn from Otsuka Pharmaceutical and Click Therapeutics is a 6-week program that helps enhance cognitive control of emotions through brief therapy lessons and training exercises.

The approval of vadadustat (Vafseo) from Akebia Therapeutics was based on data from the phase 3 INNO2VATE program.

Following quality concerns voiced by the FDA regarding plastic syringes made in China, medical technology company BD has announced it will increase its production of plastic syringes in the US.

Tenofovir alafenamide was originally approved by the FDA in 2016 to treat adults with chronic HBV infection with compensated liver disease and in 2022 to treat pediatric patients aged 12 years and older.

The approval represents the first non-statin treatment indicated to lower low-density lipoprotein for primary prevention patients.

Mirvetuximab soravtansine-gynx (Elahere) was first granted FDA accelerated approval in November 2022.

Aprocitentan (TRYVIO) from pharmaceutical company Idorsia demonstrated statistically significant and clinically meaningful reductions in blood pressure in combination with other antihypertensive therapies.