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1 week ago | 
gastroenterologyadvisor.com | Diana Ernst
Novo Nordisk is collaborating with multiple telehealth organizations in an effort to increase patient access to authentic Wegovy® (semaglutide). The Company is working with Hims & Hers Health, Inc, LifeMD, and Ro to offer all doses of Wegovy through Novo’s direct-to-patient program NovoCare Pharmacy.
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1 week ago | 
gastroenterologyadvisor.com | Diana Ernst
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a 25mg oral formulation of semaglutide for chronic weight management in adults with obesity or overweight, with 1 or more comorbid conditions, and to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease.
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1 week ago | 
empr.com | Diana Ernst
The Food and Drug Administration (FDA) has granted accelerated approval to Avmapki™ (avutometinib) plus Fakzynja™ (defactinib) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Avmapki Fakzynja Co-Pack consists of avutometinib, a rapidly accelerated fibrosarcoma/mitogen-activated protein-kinase kinase clamp, and defactinib, a focal adhesion kinase inhibitor.
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1 week ago | 
empr.com | Diana Ernst
Neffy® (epinephrine nasal spray) 1mg is now available for the emergency treatment of type 1 allergic reactions, including anaphylaxis, in pediatric patients aged 4 years and older weighing 15 to less than 30kg. The 2mg dose was made available previously for patients weighing 30kg or more. Neffy is supplied as a single-dose nasal spray that is administered into 1 nostril.
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1 week ago | 
endocrinologyadvisor.com | Diana Ernst
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.
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1 week ago | 
gastroenterologyadvisor.com | Diana Ernst
The Food and Drug Administration (FDA) has granted Orphan Drug designation to TPST-1495 for the treatment of familial adenomatous polyposis (FAP). There are currently no FDA-approved treatments for FAP, an inherited condition characterized by the proliferation of polyps in the colon and/or rectum. TPST-1495 is an oral, dual receptor inhibitor of prostaglandin (PGE2) signaling.
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1 week ago | 
endocrinologyadvisor.com | Diana Ernst
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a 25mg oral formulation of semaglutide for chronic weight management in adults with obesity or overweight, with 1 or more comorbid conditions, and to reduce the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease.
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1 week ago | 
dermatologyadvisor.com | Diana Ernst
Recommendations for the use of chikungunya vaccine were recently discussed at a meeting of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). Regarding the use of Valenva’s Ixchiq® (chikungunya vaccine, live), the ACIP recommends the following:Persons aged 18 years and older traveling to a country or territory where there is a chikungunya outbreak should receive the vaccine.
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1 week ago | 
thecardiologyadvisor.com | Diana Ernst
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for aficamten in the treatment of patients with obstructive hypertrophic cardiomyopathy. Aficamten is an oral, small molecule cardiac myosin inhibitor designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle, thereby suppressing the myocardial hypercontractility associated with hypertrophic cardiomyopathy.
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1 week ago | 
empr.com | Diana Ernst
The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy (TA-TMA). Narsoplimab is a human monoclonal antibody that specifically targets mannan-binding lectin-associated serine protease-2. It is designed to prevent complement-mediated inflammation and endothelial damage observed with TA-TMA.
