FDA announces update to NDMA testing recommendations
The FDA has released an additional NDMA testing method and has alerted the public to multiple voluntary recalls of ranitidine.
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The FDA has released an additional NDMA testing method and has alerted the public to multiple voluntary recalls of ranitidine.
Farxiga, a treatment to reduce the risk of heart failure in patients with type 2 diabetes has been approved by the FDA.
Aducanumab, an Alzheimer's disease treatment, will be submitted as part of a Biologics License Application after meeting clinical trial primary endpoints.
A business selling unapproved products containing CBD has been sent a warning letter from the FDA and FTC for making unsubstantiated claims about their therapeutic properties.
The FDA has released a statement on their generic drug approvals in FY 2019, revealing a new record high breaking above last year.
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
Torrent Pharmaceuticals has received a warning letter from the FDA for violating cGMP regulations at its manufacturing facility in India.
Reyvow (lasmiditan), for the treatment of acute migraine, has received approval from the FDA following success in clinical trials.
The FDA has approved XARELTO® (rivaroxaban) to help prevent blood clots in acutely ill medical patients.
Compounded drug products are being voluntarily recalled due a lack of sterility assurance.
Ofev, which is under review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs), has been given Breakthrough Therapy Designation.
A jury has said that Johnson & Johnson must pay $8 billion in the case over male breast growth linked to Risperdal.
The FDA has approved the first treatment to increase pain-free light exposure in patients with the rare disorder, erythropoietic protoporphyria.