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's 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.
FDA Accepts NDA for Suzetrigine to Treat Moderate, Severe Acute Pain
The investigational oral, selective NaV1.8 pain signal inhibitor from Vertex Pharmaceuticals demonstrated a favorable benefit/risk profile in 3 phase 3 trials.
Ready-to-Use Phosphorus Solution From Amneal Pharmaceuticals Wins FDA Approval
The new FDA-approved presentation will be the company’s third 505(b)(2) injectable added in 2024, expected to launch in the third quarter.
FDA Roundup: Agency Highlights from July 2024
Check out these important FDA updates from the month of July 2024.
FDA Roundup: Soliris Biosimilar, Nonerosive GERD Treatment
Check out important updates from the FDA from over the past week.
FDA Approval Marks Epysqli as Second Soliris Biosimilar
The approval of eculizumab-aagh offers more treatment options for patients with rare diseases PNH and aHUS.
With FDA Approval, Vonoprozan Offers Options for Nonerosive GERD
The approval offers a first of its kind treatment option for patients living with nonerosive GERD.