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Breakthrough therapy for cystic fibrosis approved by FDA
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
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US Food and Drug Administration (FDA)
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HER2-positive metastatic breast cancer treatment granted Priority Review
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
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Sanofi announces voluntary recall of Zantac products
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
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FDA issues warning letter to Torrent Pharmaceuticals
Torrent Pharmaceuticals has received a warning letter from the FDA for violating cGMP regulations at its manufacturing facility in India.
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First-in-class migraine treatment approved by FDA
Reyvow (lasmiditan), for the treatment of acute migraine, has received approval from the FDA following success in clinical trials.
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XARELTO® approved to help prevent blood clots
The FDA has approved XARELTO® (rivaroxaban) to help prevent blood clots in acutely ill medical patients.
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Sterile compounded drug products voluntarily recalled
Compounded drug products are being voluntarily recalled due a lack of sterility assurance.
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Breakthrough Therapy Designation granted to treatment for IDLs
Ofev, which is under review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs), has been given Breakthrough Therapy Designation.
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Johnson & Johnson ordered to pay $8bn in Risperdal case
A jury has said that Johnson & Johnson must pay $8 billion in the case over male breast growth linked to Risperdal.
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Treatment to increase pain-free light exposure approved
The FDA has approved the first treatment to increase pain-free light exposure in patients with the rare disorder, erythropoietic protoporphyria.
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Breakthrough Therapy Designation granted to prostate cancer drug
The FDA has given the designation to niraparib for the treatment of gene-mutated castration-resistant prostate cancer.
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Second PrEP preventative HIV treatment approved by FDA
The FDA has announced its approval of Descovy, a PrEP method therapy, to reduce the risk of HIV-1 infection from sex.
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FDA recommends LC-HRMS to test for NDMA in ranitidine products
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
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AstraZeneca receives FDA complete response letter for PT010
The FDA has given a complete response letter to AstraZeneca for its PT010 treatment, regarding its New Drug Application.
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First treatment for children with rare vasculitis diseases approved
Rituxan (rituximab) is the first approved treatment for children with rare vasculitis diseases, in which a patient’s small blood vessels become inflamed.
