FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs
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The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
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The U.S. Food and Drug Administration approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.
FDA approves first treatment for advanced form of the second most common skin cancer
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The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
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The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
FDA approves new kind of treatment for hairy cell leukemia
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The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
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The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs.
FDA approves treatment for two rare types of non-Hodgkin lymphoma
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The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.
More Pharma News ...
- FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation
- FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
- FDA warns of imposters sending consumers fake warning letters
- FDA takes steps to encourage more informative labeling on prescription drug and biological products' indications and usage
- FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
- FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
- FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales