FDA
*FDA Approves LIVMARLI (maralixibat) as the First and Only Approved Medication for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome One Year of Age and Older.
U.S. Food and Drug Administration (FDA) has approved LIVMARLI™ (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older.
*FDA Approves First Oral Hormone Therapy Orgovyx (relugolix) for Treating Advanced Prostate Cancer
The U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.
See more ( 18/12/2020)>>
*FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
*FDA approves Tazverik (tazemetostat) for patients with epithelioid sarcoma
The U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
See more ( 23/1/2020)>>
*FDA Approves Lokelma(sodium zirconium cyclosilicate) for Hyperkalemia.
The US Food and Drug Administration (FDA) has approved sodium zirconium cyclosilicate (Lokelma, AstraZeneca) — a medication that rapidly restores normal potassium levels — for adults with hyperkalemia.See more ( 18/5/2018)>>
*FDA Approves First-in-Class Drug Erenumab (Aimovig) for Migraine Prevention.
The US Food and Drug Administration (FDA) approved the fully human monoclonal antibody erenumab (Aimovig) for the prevention of migraine in adult patients.See more ( 17/5/2018)>>
*FDA Approves First Factor Xa Inhibitor Antidote( Andexxa).
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FDA approves Endari ( L-glutamine oral powder ) to reduce severe complications of sickle cell diseaseThe US Food and Drug Administration (FDA) has approved L-glutamine oral powder (Endari, Emmaus Medical Inc) to reduce severe complications of sickle cell disease in patients aged 5 years and older with the disorder. This is the first approval for the rare disorder in almost 20 years.
*FDA approves Bevyxxa (Betrixaban) for VTE Prophylaxis
The US Food and Drug Administration (FDA) has approved the new oral anticoagulant betrixaban (Bevyxxa, Portola) for venous thromboembolism (VTE) prophylaxis in hospitalized, acutely medically ill patients at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
*FDA Approves Baxdela (Delafloxacin )
for Skin Infections
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.
*FDA approves Ocrevus (Ocrelizumab)for Relapsing, Primary Progressive MS
The US Food and Drug Administration (FDA) has approved the humanized monoclonal antibody ocrelizumab (Ocrevus, La Roche) for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults.
*FDA Finally approves Qtern (Dapagliflozin/Saxagliptin) for Type 2 Diabetes
The US Food and Drug Administration (FDA) has approved a once-daily oral fixed-dose medication, called Qtern, combining 5 mg of the DPP-4 inhibitor saxagliptin (Onglyza, AstraZeneca) and 10 mg of the SGLT2 inhibitor dapagliflozin (Forxiga/Farxiga, AstraZeneca) for the treatment of type 2 diabetes in adults.
*FDA approves Siliq (brodalumab)
for plaque Psoriasis
The US Food and Drug Administration (FDA) today approved an injectable biologic called brodalumab (Siliq, Valeant Pharmaceuticals) to treat adults with moderate-to-severe psoriasis, but the approval comes with important yellow flags.
* FDA approves Spinraza (nusinersen) , First Drug for Spinal Muscular Atrophy
The US Food and Drug Administration (FDA) has approved nusinersen (Spinraza, Biogen and Ionis Pharmaceuticals), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease.
*FDA Approves Rubraca (rucaparib) for BRCA Ovarian Cancer.
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.
* FDA Approves Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes.
The US Food and Drug Administration (FDA) has approved prasterone (Intrarosa, Endoceutics Inc) to treat women with moderate to severe pain during sexual intercourse (dyspareunia) associated with menopause. See more ( 17/11/2016)>>
*FDA Approves Zinplava (bezlotoxumab ) for Preventing Return of Clostridium difficile infection.
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 Sustol (granisetron) for Chemotherapy-Induced Nausea.
U.S. Food and Drug Administration (FDA) has approved Heron's drug Sustol (granisetron) to prevent chemotherapy-induced nausea and vomiting.
*FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older
The U.S Food and Drug Administration (FDA) approved Qbrelis (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults.See more ( 29/7/2016) >>
*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) >>
*FDA Approves Vaxchora (Cholera Vaccine, Live, Oral) to Prevent Cholera in TravelersThe U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.See more ( 10/6/2016) >>
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) >>
*FDA Approves Taltz (ixekizumab) for Plaque Psoriasis.
The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis.
*FDA approves Praxbind (idarucizumab), the first reversal agent for the anticoagulant Pradaxa (dabigatran)
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)>>
*FDA approves Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) for diabetes mellitus
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
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*FDA Approves Envarsus XR (tacrolimus) for Prevention of Organ Rejection in Kidney Transplant Patients
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)>>
*FDA approves Viberzi (eluxadoline) and Xifaxan (rifaximin) to treat IBS-D
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)>>
*FDA approves Corlanor(ivabradine) to treat heart failure
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)>>
*FDA approves Avycaz (ceftazidime-avibactam) For the treatment of complicated intra-abdominal and urinary tract infections
The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options. See more ( 25/2/2015)>>
*FDA approves Savaysa( edoxaban tablets) to treat atrial fibrillation, deep vein thrombosis, and pulmonary embolism
The U.S. Food and Drug Administration approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. See more ( 8/1/2015)>>
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 today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes). See more (23/4/2104)>>
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
The U.S. Food and Drug Administration approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.The drug’s safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).
see more (15/4/2014)>>
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)>>
The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
*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 ,
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*FDA approves Myalept (metreleptin for injection) to treat rare metabolic disease
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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)>>
The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. See More(18/2/2014)>>
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*FDA approves Mekinist in combination with Tafinlar for advanced melanoma
This week the U.S. Food and Drug Administration approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage).See More(10/1/2014)>>
*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
More (8/1/2014)>>
*FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation.
FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.see more (8/1/2014)>>
The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency. see more (23/12/2013) >>
In 12/17/2013 the FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism.see more>>
