Archive for the 'FDA' Category

J&J and FDA issue warning to doctors about reports of dangerous skin reactions with HIV drug

Wednesday, August 26th, 2009

J&J warns of allergic reactions with HIV drug
WASHINGTON — Johnson & Johnson has warned doctors about reports of potentially deadly allergic reactions in patients taking its HIV drug Intelence.

Anti-obesity drug’s safety being reviewed amid liver damage fears

Wednesday, August 26th, 2009

LONDON - Authorities in the U.S. probing whether an anti-obesity drug being sold over the counter may cause liver damage.

Food and Drug Administration authorizes emergency use of swine flu test for troops overseas

Wednesday, August 26th, 2009

Swine flu test authorized for troops overseas
WASHINGTON — The Food and Drug Administration said Tuesday it has authorized the emergency use of a swine flu test for U.S. troops overseas, allowing the military to speed up diagnoses and treatment of a virus that could cause widespread infections again this fall.

FDA probes reports of liver damage with alli and prescription version of weight loss drug

Monday, August 24th, 2009

FDA probes liver damage with weight loss pill alli
WASHINGTON — The Food and Drug Administration is investigating reports of liver damage in patients taking alli, the only nonprescription weight loss drug approved by the agency.

First non-surgical procedure to prevent major cause for heart-related stroke performed in US

Saturday, August 22nd, 2009

WASHINGTON - A pair of Indian-origin physicians at The Mount Sinai Medical Center become the first doctors in America to perform a non-surgical procedure using sutures to tie off a left atrial appendage (LAA), the source of blood clots leading to stroke in patients [...]

Lundbeck’s Sabril first drug approved by FDA for treatment of rare seizure disorder in infants

Friday, August 21st, 2009

FDA approves first drug for infantile spasms
WASHINGTON — The Food and Drug Administration on Friday approved the first drug to treat infantile spasms, a rare disorder that can cause hundreds of seizures per day in children less than a year old.

FDA issues warnings to 8 companies for marketing unapproved ibuprofen-based ointments

Thursday, August 20th, 2009

FDA cracks down on ibuprofen pain relief gels
WASHINGTON — The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofen.

Sugary ‘energy’ bars, fattening probiotic ice cream: Consumers devour amped-up foods, drinks

Thursday, August 20th, 2009

Consumers devouring nutrient-spiked foods, drinks
MILWAUKEE — From heart-friendly margarines to sugary cereals that strengthen bones, once-demonized foods are being spiked with nutrients to give them a healthier glow — and consumers are biting, even on some that are little more than dressed-up junk food.

Lung cancer pill Iressa beats chemo for certain patients, new study concludes

Wednesday, August 19th, 2009

Study: Lung cancer pill works for some patients
ATLANTA — Four years after the government severely restricted its use, the lung cancer drug Iressa may be poised to make a comeback: A study concludes it can slow the deadly disease better than standard chemotherapy in certain patients.

Johnson & Johnson gets FDA warning letter on monitoring and conduct of ceftobiprole studies

Wednesday, August 19th, 2009

FDA warns Johnson & Johnson on antibiotic trials
NEW YORK — The Food and Drug Administration has warned Johnson & Johnson that it did not properly monitor two human tests of its antibiotic drug candidate ceftobiprole, which is intended to treat complicated skin infections like MRSA.

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