FDA Updates

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.

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.

The approval was based on data from the phase 1/2 TRANSCEND CLL 004 study, in which the CAR T cell therapy demonstrated statistically significant complete response rates.

The approval, awarded to Madrigal Pharmaceuticals, was based on phase 3 data demonstrating that resmetirom achieved broad treatment effects in patients with MASH with liver fibrosis.

Study results demonstrated the efficacy of semaglutide (Wegovy) in reducing cardiovascular risks in adults with overweight or obesity without diabetes.

A clinical trial showed that nivolumab plus chemotherapy significantly improved overall survival and progression-free survival compared with a chemotherapy combination alone.

This is the fifth oncology indication for zanubrutinib in the United States.

Dexcom's Stelo will be available in summer 2024.

The agency approved denosumab-bddz under two brand names: Wyost and Jubbonti.

June 7, 2024 is the target PDUFA date for the additional indication of GSK's respiratory syncytial virus vaccine Arexvy.

Eosinophilic esophagitis is a chronic, progressive disease thought to be responsible for damaging the esophagus, and it can severely impact a child’s ability to eat.

The NDA was submitted for investigational muscarinic antipsychotic, KarXT (xanomeline-trospium), which functions as a dual M1/M4 muscarinic acetylcholine receptor agonist within the central nervous system.

The perfluorohexyloctane ophthalmic solution from Bausch + Lomb was approved by the FDA in May and will have a whole acquisition cost of $771 for a one-month supply.

Lodoco (colchicine) approval was based on a clinical trial with 5,522 patients with chronic coronary disease, which was published in Circulation in February 2022.

The medication is broadly approved for heart failure with preserved or reduced ejection fraction.