The US Food and Drug Administration (FDA) today approved an antibiotic called delafloxacin (Baxdela, Melinta Therapeutics) to treat serious or life-threatening infections, including one that's particularly tough to beat.
The US Food and Drug Administration (FDA) today granted accelerated approval to the oral therapy rucaparib (Rubraca, Clovis Oncology) for the treatment of women with advanced ovarian cancer who have received two or more prior chemotherapies and whose tumors have a BRCA gene mutation.
See more ( 19/12/2016)>>
U.S. Food and Drug Administration (FDA) has approved bezlotoxumab injection (Zinplava, Merck) to reduce the recurrence of Clostridium difficile infection (CDI) in patients aged 18 years or older. See more ( 24/10/2016)>>
* FDA Approves Yosprala (aspirin and omeprazole) for Secondary Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers.
U.S. Food and Drug Administration (FDA) has approved once-daily Yosprala, the only prescription fixed-dose combination of aspirin and omeprazole in the U.S. Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. See more ( 15/9/2016)>>
*FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
U.S. Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3).
See more ( 17/6/2016) >>
The US Food and Drug Administration (FDA) has approved the first long-acting muscarinic antagonist/long-acting beta-2 agonist combination (glycopyrrolate and formoterol fumarate)
in a pressurized metered-dose inhaler (pMDI), using novel co-suspension technology for chronic obstructive pulmonary disease (COPD), according to an AstraZeneca release.
see more ( 27/4/2016) >>
The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. See more ( 16/10/2015)>>
The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. See more ( 25/9/2015
U.S. Food and Drug Administration (FDA) approved Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.
See more ( 10/7/2015)>>
The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. See more ( 27/5/2015)>>
The U.S. Food and Drug Administration approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.See more (15/4/2015)>>
The U.S. Food and Drug Administration today approved Zontivity
(vorapaxar) tablets to reduce the risk of heart attack, stroke,
cardiovascular death, and need for procedures to restore the blood flow
to the heart in patients with a previous heart attack or blockages in
the arteries to the legs.
see more (8/5/2014)>>
The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.
*FDA approves Topamax for migraine prevention in adolescents.
the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group.
See more (28/3/2014)>>
*FDA approves Otezla to treat psoriatic arthritis.
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were evaluated in three clinical trials ,
*FDA approves Myalept (metreleptin for injection) to treat rare metabolic disease
The U.S. Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. See More (25/2/2014)>>
*FDA approves Mekinist in combination with Tafinlar for advanced melanoma
*FDA approves Farxiga to treat type 2 diabetes.
The U.S. Food and Drug Administration today approved Farxiga
(dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults
with type 2 diabetes. See