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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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US Food and Drug Administration (FDA)
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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.
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Daratumumab approved for multiple myeloma treatment
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
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FDA approves vaccine for smallpox and monkeypox
The Jynneos live, non-replicating vaccination for smallpox and monkeypox has been approved by the FDA for high-risk patients.
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The 10 latest FDA Orphan Drug Designations for cancer treatments
The FDA grants Orphan Drug Designation to treatments for rare diseases in R&D; here are the 10 most recent for oncologic conditions.
