Mylan received approval from FDA to market its desvenlafaxine extended-release tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently received approval for their generic versions of Pristiq.
FDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, AstraZeneca), to treat type 2 diabetes.
FDA recently approved three novel drugs: one to treat frequent urination at night, one to treat carcinoid syndrome diarrhea in cancer patients, and one for dust mite allergies. Here are the details on the three new treatments.
A dual-drug regiment to treat HIV could soon be a reality, according to results presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
FDA recently approved 2 tests that will aid healthcare providers in determining which antibiotics are needed, leading to better antibiotics management.
A new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.
A leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.
Marathon Pharmaceuticals is temporarily pausing the launch of its drug to treat a rare form of muscular dystrophy (MD) after concerns over its $89,000 price tag.
FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
FDA is warning about rare but serious allergic reactions have from the widely-used skin antiseptic products containing chlorhexidine gluconate.
In the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.
Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.
FDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.
McKesson Corp., one of the largest distributors of pharmaceuticals, agreed to pay a record civil penalty for alleged violations of the Controlled Substances Act.
FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
FDA recently approved a long-acting opioid designed to deter abuse.
While President-elect Donald Trump recently said that the pharmaceutical industry is “getting away with murder” in terms of drug prices, the industry is trying to self-regulate before facing tighter rules from the incoming administration.
FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.
Consumer health groups are praising Health and Human Services’ (HHS) new rule on the Medicaid 340B drug discount program, which sets a ceiling on drug prices.
FDA recently expanded approval of the G5 Mobile Continuous Glucose Monitoring System (Dexcom) to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.
While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.
FDA approved nusinersen (Spinraza, Biogen), the first drug to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.
A new combination drug for type 2 diabetes will available in the US in the coming months.
FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.
FDA recently approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.
