EPIZYME: Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma
TAZVERIK Now Approved for Second Indication
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FDA plans 24 public meetings in November
The U.S. Food and Drug Administration (FDA) has scheduled 24 public meetings, conferences and workshops for November, the agency reported.
Physicians committee wants FDA to require breast cancer warnings on cheese products
The Physicians Committee for Responsible Medicine (PCRM) has filed a petition with the U.S. Food and Drug Administration (FDA) that would require a warning label on all dairy cheese products warning about the potential increased risks of developing breast cancer.
FDA Update: September inspection citations
The U.S. Food and Drug Administration (FDA) inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
FDA Update: September medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration (FDA).
Washington Policy Center analyst says black-market THC products to blame for vaping deaths, illnesses
As Congress criticizes the Food and Drug Administration (FDA) for its 2017 delay of reviewing e-cigarettes and vaping products, and blames the agency for the current vaping-illness outbreak across the U.S., Washington Policy Center Health Care Policy Analyst Roger Stark, M.D., is stressing to the nation that the FDA should not be held responsible for the recent surge in health emergencies.
FDA plans 19 public meetings in October
Nineteen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for October, the FDA reported.
FDA taken to task over opioid approval process
Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.
Expanded recall set for blood pressure medication Losartan
Torrent Pharmaceuticals recently announced it was expanding its recall for Losartan potassium tablets and Losartan potassium/hydrochlorothiazide tablets.
Torrent's recall of drug to treat hypertension expanded
The recall of medications manufactured by Torrent Pharmaceuticals Ltd. to treat high blood pressure conditions has been expanded, the U.S. Food and Drug Administration reported.
Peanut allergy treatment moves closer to FDA approval
A treatment for peanut allergies took another step toward becoming a reality as the Allergenic Products Committee voted to advise the U.S. Food and Drug Administration (FDA) this month during the approval process.
FDA Update: August inspection citations
The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
FDA approves treatment for rare lung disease scleroderma
The treatment involves taking Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, which is called SSc-ILD.
&&& Science group calls FDA fast-track approval of nasal spray shocking
The Center for Responsible Science (CRS) said it is shocking that the Federal Drug Administration (FDA) granted fast-track approval for a nasal spary based on a two-day study of 30 trial participants because it was fast-acting and later declined to label the drug fast-acting on approval.
FDA confirms guidance on placebos, blinding for cancer trials
The Food and Drug Administration (FDA) made a recommendation to drugmakers last week stating that they only use placebos in cancer clinical trials in select circumstances.
FDA Update: July facility inspection results
The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
FDA Update: August medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Sen. Durbin calls for more e-cigarette product regulation from FDA
Following the death of an Illinois citizen who suffered from respiratory illness after vaping, Sen. Dick Durbin (D-IL) sent a letter to the Food and Drug Administration and the Center for Tobacco Products demanding that they remove e-cigarettes and related vaping products off of the market.
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Doctors see good things with new scoliosis treatment recently approved by FDA
A doctor based at Johns Hopkins in Baltimore sees the new treatment for scoliosis recently approved by the U.S. Food and Drug Administration as a viable option for young patients.
Drawbridge Health's new blood collection device receives 510(k) clearance
Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.