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The US Food and Drug Administration (FDA) has released the first of two new pieces of draft guidance that may eventually enable e-cigarette manufacturers to apply for regulated drug status for their products. FDA Commissioner Scott Gottlieb, MD, said there is “no greater impact we can...
Read MoreThe US Food and Drug Administration (FDA) has approved Azedra (iobenguane I 131), the first drug approved for treatment of rare unresectable adrenal gland tumors that spread beyond the original tumor site and need treating with a systemic anti-cancer therapy. Adrenal glands, situated above...
Read MorePatients with neutropenia may have improved access to treatment following the US Food and Drug Administration’s (FDA’s) approval of Nivestym (filgrastim-aafi), a biosimilar for Amgen biologic Neupogen (filgrastim). The FDA’s approval of the biosimilar was based on a review...
Read MoreStreamlining the process of bringing biosimilars to market is one of the keys to facilitating innovation and reducing healthcare costs, according to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb. Speaking at the Brookings Institution on the release of the FDA’s...
Read MoreLast week, Tibsovo (ivosidenib), a new targeted therapy for the treatment of certain adult patients with relapsed or refractory acute myeloid leukemia (AML) with a specific genetic mutation, was approved by the US Food and Drug Administration. Richard Pazdur, MD, director of the FDA’s...
Read MoreThe US Food and Drug Administration (FDA) is examining ways to empower consumers by improving access to a range of non-prescription and over-the-counter (OTC) medication and drug products. OTC drugs, such as Tylenol (acetaminophen) or Claritin (loratadine), are considered the first line treatment...
Read MoreEpidiolex (cannabidiol) is the first medication based on a purified drug substance, cannabidiol (CBD), derived from marijuana to gain approval from the US Food and Drug Administration (FDA). The drug is indicated for patients aged two years and older with Lennox-Gastaut syndrome or Dravet...
Read MoreManagement of type 1 diabetes in pediatric patients could become easier following the approval of an automated insulin delivery and monitoring system for use in children between the ages of seven and 13. Medtronic’s MiniMed 670G hybrid closed loop system monitors glucose levels and...
Read MoreAmericans suffering from severe emphysema now have a new treatment option available following the decision by the US Food and Drug Administration (FDA) to approve the Zephyr Endobronchial Valve, or Zephyr Valve. The device, marketed by Pulmonx Inc, is placed into diseased areas of the lungs by a...
Read MorePatients with type 1 or type 2 diabetes now have a new option for monitoring their glucose levels following the US Food and Drug Administration’s (FDA) decision to approve the first continuous glucose monitoring (CGM) system with a fully implantable sensor. The Eversense CGM can be...
Read MorePatients struggling to break dependence on opioids will soon have a cheaper treatment option available following the US Food and Drug Administration’s (FDA) decision to approve the first generic sublingual version of Suboxone (buprenorphine and naloxone). In April 2017, the US...
Read MoreA new treatment option will soon be available for children aged five and over with asthma following the US Food and Drug Administration’s (FDA) decision to expand its approval of the GlaxoSmithKline (GSK) Arnuity Ellipta (fluticasone furoate) inhaler. The medication was first approved...
Read MoreA “novel” new preventative treatment for migraines in adults, which works by blocking the activity of a molecule involved in migraine attacks, has been approved by the US Food and Drug Administration (FDA). Approval for Aimovig (erenumab-aooe) was granted to Amgen Inc following three...
Read MorePatients with anemia caused by chronic kidney disease, chemotherapy, or those with HIV who take Retrovir (zidovudine) will soon have a new medication option in the form of Retacrit (epoetin alfa-epbx). The drug is the first biosimilar for epoetin-alfa to gain US Food and Drug Administration (FDA)...
Read MoreThe US Food and Drug Administration (FDA) has granted approval to Gilenya (fingolimod) as a treatment for children and adolescents with multiple sclerosis (MS). The Novartis medication is the first drug approved by the FDA for treatment of pediatric patients with MS. Gilenya first gained FDA...
Read MoreThe US Food and Drug Administration (FDA) has approved the protein kinase inhibitor Tagrisso (osimertinib) as a first-line treatment option for certain patients with metastatic non-small cell lung carcinoma (NSCLC). Earlier this month, AstraZeneca presented new data from a Phase III FLAURA trial...
Read MoreThe US Food and Drug Administration (FDA) has approved Crysvita (burosumab) as a treatment for a rare form of inherited rickets. It is the first drug therapy approved as a treatment for x-linked hypophosphatemia (XLH) with evidence of bone disease in children over one year of age and adolescents...
Read MoreThe US Food and Drug Administration (FDA) has permitted marketing of a medical device that utilizes artificial intelligence (AI) to detect certain eye problems related to diabetes. It is the first device of its kind to harness AI to detect diabetic retinopathy considered greater than a mild level...
Read MoreCancer medication Blincyto (blinatumomab) has received accelerated approval as a treatment to reduce the risk of relapse in certain patients with B-cell precursor acute lymphoblastic leukemia (ALL). Under the latest US Food and Drug Administration (FDA) approval, Blincyto is indicated for adults...
Read MoreThe US Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The Sun Pharma drug was granted approval following two Phase 3 clinical trials featuring 926...
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