FDA Updates

The therapy from AstraZeneca is indicated to improve glycemic control in patients aged 10 years or older.

The Lingo and Libre Rio from Abbott are based on the company’s FreeStyle Libre sensing technology.

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses how some of the concern’s raised by the panel can inform future psychedelic research.

The new task force highlights a stronger government focus on curbing the risks of e-cigarettes for young people, especially after sustained calls for stricter action on the public health issue by lawmakers and the public.

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, talks about some of the problems he saw during the Psychopharmacologic Drugs Advisory Committee meeting.

Check out important updates from the FDA for the week of June 3.

The Psychopharmacologic Drugs Advisory Committee voted 10-1 that the benefits of MDMA do not outweigh its potential risks.

The SpeedySwab COVID + FLU A&B Self-Test from Watmind is intended for at-home and point-of-care use and can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes.

mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19.

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

The approval of Lisocabtagene maraleucel (Breyanzi; liso-cel) was based on data from the TRANSCEND-NHL-001 study, in which the therapy showed rapid and durable response rates.

The drug will be available in pharmacies during the second half of 2024.

Eculizamab-aeeb is the 53rd FDA-approved biosimilar in the US.

Check out important updates from the FDA for the week of May 20.

Berdazimer topical gel is the first in its class and is the only topical prescription medication to treat molluscum contagiosium that can be applied by patients or caregivers outside of a medical setting.

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.

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.