Articles related to DEVICE/DRUG APPROVALS

The FDA’s approval of new COVID-19 vaccines targeting the KP.2 strain comes amidst concerns about waning immunity and evolving virus variants.

Erzofri offers a new once-monthly injectable option for treating schizophrenia and schizoaffective disorder, potentially improving medication adherence for some patients.

Lisocabtagene maraleucel offers a new treatment option for patients with CLL who have progressed on both BTK and BCL2 inhibitors, addressing an important unmet need in this patient population.

Neffy®, an FDA-approved intranasal epinephrine spray, demonstrates bioequivalence to injectable epinephrine for anaphylaxis treatment in patients weighing ≥30kg, potentially reducing barriers to rapid intervention.

Zunveyl, a prodrug of galantamine, has been formulated to minimize gastrointestinal absorption, potentially addressing common tolerability issues associated with acetylcholinesterase inhibitors in Alzheimer’s treatment.

Afamitresgene autoleucel offers a novel approach to treating metastatic synovial sarcoma, with an overall response rate of 43.2% in clinical trials, providing a much-needed alternative to traditional chemotherapy.