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.
FDA, FTC Issue Warnings to Companies Selling Copycat Food Products Containing Delta-8 THC
The companies are marketing products that may violate Federal Trade Commission prohibition of “unfair and deceptive acts in the marketplace.”
Novo Nordisk Once-Weekly Insulin Faces Approval Setback With CRL
Had Novo Nordisk’s insulin icodec secured FDA approval, it would have been the first and only once-weekly basal insulin option for adults with diabetes.
FDA Approves Roflumilast Cream 0.15% for Atopic Dermatitis in Pediatric, Adult Patients
The commercial product is expected to be available by the end of July.
FDA Approves Donanemab (Kisunla) For Early Symptomatic Alzheimer Disease
Donanemab-azbt was approved under the FDA's Fast Track Review, Priority Review, and Breakthrough Therapy designations.
FDA Authorizes Marketing of First-Ever Point-of-Care Hepatitis C RNA Test
Through a test-and-treat approach, patients who test positive for HCV RNA with the Xpert HCV test and GeneXpert Xpress System can be connected to care as soon as the same health care visit.
FDA Roundup: Agency Highlights From June 2024
Check out these important FDA updates from the month of June 2024.
FDA Approves Ensifentrine for Treatment of COPD
The first-in-class selective dual PDE3 and PDE4 inhibitor from Verona Pharma is the first inhaled product with a novel mechanism of action approved to treat COPD in over 20 years.
Teva Pharmaceuticals Launches Liraglutide Injection 1.8 mg, First Generic GLP-1 in the US
The Victoza generic is approved for use in adults and children aged 10 years and older.
FDA Roundup: Pneumococcal Conjugate Vaccine, Ulcerative Colitis Treatment
Check out important updates from the FDA for the week of June 17.
FDA: Exblifep Approved for Complicated Urinary Tract Infections
Cefepime/enmetazobactam was granted a 5-year exclusivity extension under GAIN Act legislation.
FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive
The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.
FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes
The therapy from AstraZeneca is indicated to improve glycemic control in patients aged 10 years or older.
FDA Approves 2 New OTC Continuous Glucose Monitors
The Lingo and Libre Rio from Abbott are based on the company’s FreeStyle Libre sensing technology.
