FDA Updates

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.

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.

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.