Government Agencies FDA

  • Dec 20- Acadia Pharmaceuticals Inc said on Tuesday its drug to treat psychosis in patients suffering from Alzheimer's disease met its main goal in a mid-stage study. The drug has been approved by the US Food and Drug Administration to treat hallucinations and delusions associated with Parkinson's disease psychosis, the company said. Acadia said the FDA is yet...

  • Biotech

    Clovis Oncology shares jumped 15 percent Monday after the FDA approved Rubraca (rucaparib), the company's advanced ovarian cancer drug.

  • The drug, rubraca, which secured approval about two months earlier than scheduled, targets patients whose tumors have a mutation called BRCA, identifiable using an FDA- approved companion diagnostic test. The FDA also approved on Monday a test made by Foundation Medicine Inc to help detect the presence of BRCA mutations. About 15-20 percent of ovarian cancer...

  • Dec 19- The U.S. Food and Drug Administration said it had granted accelerated approval to Clovis Oncology Inc's ovarian cancer drug in patients with a specific gene mutation whose disease advanced despite two or more rounds of chemotherapy. The drug, Rubraca, secured approval about two months earlier than expected for patients whose tumors have a specific...

  • The drug, Rubraca, secured approval for patients whose tumors have a specific gene mutation called BRCA- identified by an FDA- approved companion diagnostic test, the FDA said. The FDA on Monday also approved a diagnostic test made by Foundation Medicine Inc to detect the presence of BRCA gene mutations. About 15-20 percent of ovarian cancer patients have the...

  • Dec 19- The U.S. Food and Drug Administration said on Monday it approved Clovis Oncology Inc's ovarian cancer drug.

  • Pfizer, which has spent heavily on advertising for and settling lawsuits against Chantix, failed to get rid of the warning in 2014 after the FDA decided to wait for additional trial data. Based on the data, an independent panel to the FDA in September narrowly voted in favor of removing the warning, arguing that the benefits of Chantix outweighed the demerits of...

  • Agios drops drug for blood disorder due to side effects

    Shares of Agios Pharmaceuticals are plunging on news that the company will discontinue the AG-519 drug. CNBC's Meg Tirrell reports.

  • Dec 14- A Pfizer Inc ointment to treat mild to moderate cases of the itchy skin condition eczema, or atopic dermatitis, won U.S. approval for use in patients aged two years and older, the Food and Drug Administration said on Wednesday. Pfizer, which acquired the drug through its $5.2 billion purchase of Anacor Pharmaceuticals earlier this year, has estimated...

  • Dec 14- The U.S. Food and Drug Administration left open the door on Wednesday for Swedish Match AB to claim its snus smokeless tobacco products represent a substantially lower risk to health than cigarettes. The FDA said evidence showed the products could cause gum disease and tooth loss. "There doesn't seem to be a disagreement between the company and the FDA as...

  • Dec 14- The U.S. Food and Drug Administration on Wednesday said it approved Pfizer Inc's ointment to treat mild to moderate cases of the itchy skin condition eczema, or atopic dermatitis, for use in patients aged two years and older. The topical drug, crisaborole, will be sold under the brand name Eucrisa, the FDA said. Pfizer, which bought Anacor Pharmaceuticals for...

  • Dec 14- The U.S. Food and Drug Administration said on Wednesday it had approved Pfizer Inc's Eucrisa ointment to treat mild-to-moderate eczema, or atopic dermatitis, in patients two years and older. Atopic dermatitis is the most common of the many types of eczema, typically beginning in childhood and possibly lasting through adulthood. Pfizer bought Anacor...

  • Dec 14- The U.S. Food and Drug Administration left open the door on Wednesday for Swedish Match AB to claim its snus smokeless tobacco products represent a substantially lower risk to health than cigarettes. The FDA said evidence shows the products can cause gum disease and tooth loss. "There doesn't seem to be a disagreement between the company and the FDA as to...

  • Dec 14- The U.S. Food and Drug Administration said on Wednesday it denied Swedish Match AB's request to remove a currently required warning stating that its eight smokeless tobacco products can cause gum disease and tooth loss. The FDA authorized the sale of eight smokeless tobacco products known as "snus" under its "General" brand by Swedish Match last year.

  • Dec 14- Intercept Pharmaceuticals Inc said its liver drug received conditional approval from the European Commission to treat patients with primary biliary cholangitis, a rare liver condition. Intercept's shares rose about 4 percent to $113.00 in premarket trading on Wednesday. The U.S. Food and Drug Administration granted an accelerated approval to the...

  • The privately owned companies- Swisher International Inc, Cheyenne International LLC, Prime Time International Co and Southern Cross Tobacco Co Inc- are selling the products under brands such as "Swisher Sweets", "Cheyenne", "Prime Time" and "Criss-Cross" in youth-appealing flavors such as grape, wild cherry and strawberry, the FDA said. "Flavored cigarettes appeal...

  • Dec 9- The U.S. Food and Drug Administration has issued warning letters to four tobacco manufacturers for selling flavored cigarettes labeled as cigars, the agency said on Friday. The companies- Swisher International Inc, Cheyenne International LLC, Prime Time International Co and Southern Cross Tobacco Co Inc- are selling the products under brands such as "...

  • Dec 8- Horizon Pharma Plc's shares tumbled 18 percent after the company ended a late-stage trial that was testing its drug, Actimmune, as a treatment for a rare neuromuscular disorder that has no approved medicines. The drug is already approved by the U.S. Food and Drug Administration for use in two rare, genetic conditions- chronic granulomatous disease and...

  • The drug failed to demonstrate a statistically significant benefit over a placebo after 26 weeks on a rating scale that measures parameters of disease progression, the Ireland- based company said. Actimmune is already approved by the U.S. Food and Drug Administration for use in two rare, genetic conditions- chronic granulomatous disease and severe, malignant...

  • Jim O'Neill considered for FDA commissioner

    CNBC's Meg Tirrell reports on who may be leading the FDA under a Trump presidency.