FDA Approves First-Ever OTC Hearing Aid Software
Over 30 million American adults experience some hearing loss, yet only one-fifth benefit from hearing aids; the FDA’s approval will expand access to the technology for the patient population.
FDA Roundup: Apple AirPods Hearing Aids, Tremfya for Ulcerative Colitis
Check out important updates from the FDA for the week of August 9.
FDA Approves Nymalize in Prefilled ENFit Syringes
Nymalize is an effective alternative to capsule extraction for adult patients with subarachnoid hemorrhage who are unable to swallow capsules.
FDA Roundup: Novavax COVID-19 Vaccine, First Digital Therapeutic for GAD
Check out important updates from the FDA for the week of September 2.
FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder
DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.
FDA Clears New Disposable Insulin Patch Pump for Patients With T1D and T2D
Embecta’s new patch pump offers a larger insulin reservoir to better accommodate for the needs of patients with type 2 diabetes (T2D).
FDA Authorizes IND For Phase 2 Clinical Trial Evaluating Treatment for Post–COVID-19 Condition
Bezisterim acts on inflammatory signaling pathways and may be a viable treatment option for post–COVID-19 condition, or long COVID.
FDA Approves Updated Novavax COVID-19 Vaccine
The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 strain.
FDA Approves Expanded Use of ACAM2000 Vaccine for Mpox Amid Public Health Emergency
Emergent BioSolutions has announced that it will donate 50,000 doses of ACAM2000 for potential deployment across affected areas in Central Africa.
FDA Roundup: Agency Highlights from August 2024
Checkout these important FDA updates from the month of August 2024.
Omnipod 5 FDA Cleared for Use in Adults With Type 2 Diabetes
The device was previously cleared for use in children and adults with type 1 diabetes.
FDA Roundup: Updated COVID-19 Vaccines, Treprostinil for PAH Associated With PH-ILD
Check out important updates from the FDA for the week of August 19.
COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations
Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.
Amneal Pharmaceuticals Receives FDA Approval for Propofol Injectable Emulsion Single-Dose Vials
FDA approval of Amneal Pharmaceuticals' propofol injectable emulsion single-dose vials aims to address the drug’s history of chronic supply issues.
FDA Grants Tentative Approval to Treprostinil for PAH Associated With PH-ILD
Final approval of the therapy may occur after expiration of the 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.
FDA Grants Marketing Authorization to First-Ever OTC Syphilis Test
First To Know Syphilis Tests are expected to be available at major national retailers and online in late 2024.
FDA Roundup: First Treatment for Hypoparathyroidism, Disposable CGM Approval
Check out important updates from the FDA for the week of August 12.
FDA Approves Medtronic’s Disposable CGM
Medtronic also announced it has entered a global partnership with Abbott in an effort to expand CGM device options for patients living with diabetes.
FDA Approves First Monoclonal Antibody to Treat Prurigo Nodularis
Two phase 3 trials evaluating nemolizumab found that 41% of patients treated with the therapy achieved at least a 4-point reduction in itch intensity at week 16.
FDA Approves First Treatment for Hypoparathyroidism in Adults
Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.
FDA Rejects MDMA-Assisted Therapy to Treat PTSD in Setback for Psychedelic Medicine
The agency said it could not approve the new drug application based on the submitted data and requested an additional Phase 3 trial to “further study the safety and efficacy” of the therapy.
FDA Approves First Needle-Free Epinephrine Nasal Spray
The epinephrine nasal spray from ARS Pharmaceuticals has become the first and only needle-free epinephrine alternative and the first new delivery method for epinephrine in over 3 decades.
FDA Roundup: Implications of Potential MDMA Approval, Nalmefene for Opioid Overdose
Check out important updates from the FDA for the week of August 5.
As FDA Decision on MDMA for PTSD Looms, What Would Approval Mean for Mental Health Treatment?
Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.
FDA Approves Extended-Release Parkinson Medication From Amneal Pharmaceuticals
In a clinical trial, IPX203 was able to achieve longer good on-time with less doses compared to standard treatment.
FDA Approves Nalmefene Injection for Opioid Overdose
Nalmefene injection is an opioid receptor antagonist and comes in a single-dose, pre-filled auto-injector that delivers 1.5 mg of the medication per actuation.
FDA Roundup: Cell Therapy Approval, Warning Issued for At-Home Chemical Peels
Check out important updated from the FDA for the week of July 29.
FDA Grants Accelerated Approval to First Engineered Cell Therapy for Synovial Sarcoma
Afami-cel is the first new treatment for synovial sarcoma in more than 10 years, ending a long-standing therapeutic gap.
FDA Warns Against Using At-Home Chemical Peels, Cites Retailers
Pharmacists should be knowledgeable about the symptoms of chemical peel irritation to effectively advise patients.
FDA to Weigh Bayer’s Treatment for Hot Flashes Associated with Menopause
In 3 Phase 3 trials, elinzanetant reduced the frequency and severity of moderate to severe vasomotor symptoms, and improved sleep disturbances.