
The FDA is considering approval for a liquid bendamustine hydrochloride rapid infusion product.
The FDA is considering approval for a liquid bendamustine hydrochloride rapid infusion product.
TAF shows signs of improved renal and bone parameters compared with Viread in clinical trials.
The levonorgestrel-releasing intrauterine system can prevent pregnancy for up to 3 years.
Gilead Sciences is seeking FDA approval for emtricitabine/tenofovir alafenamide.
The FDA has granted priority review to Shire's lifitegrast treatment.
The FDA refused to approve Novo Nordisk's ultra-long-acting insulin treatments 2 years ago.
Combination fast-tracked for approval to treat chronic HCV GT1 infection in end-stage renal disease patients on hemodialysis.
The FDA has granted 2 breakthrough therapy designations to grazoprevir/elbasvir.
Even though Shire is seeking an adult indication for its investigational ADHD treatment, the FDA is requesting pediatric data before deliberating the drug's approval.
Mylan has launched the first generic version of the chewable contraceptive.
Actavis is seeking FDA approval for its generic version of Gilead Sciences' Letairis pulmonary arterial hypertension treatment.
The FDA has outlined the type of studies opioids need to complete to win approval for abuse-deterrence.
Shire's self-administered parathyroid hormone (Natpara) is now available in the United States.
Teva, Mylan, and Sandoz announced the US launches of their generic equivalents to Novartis's Exforge.
Kyprolis has already been approved for patients who failed at least 2 previous therapies.
The FDA has granted priority review status to Amgen's supplemental New Drug Application for its carfilzomib (Kyprolis) cancer therapy.
The FDA refused to approve the ultra-long-acting insulin treatments 2 years ago.
Teikoku Pharma USA has submitted a New Drug Application to the FDA for the product.
The enhanced system gives eye care professionals the ability to safely deliver an intraocular lens through incisions as small as 2.2 mm.
Zyprexa Relprevv's label and recommended use remain unchanged.
Shire's ADHD treatment, lisdexamfetamine dimesylate (Vyvanse), is now available in a 10-mg titration dose.
Nearly one in 5 adults with epilepsy show symptoms of attentiondeficit/ hyperactivity disorder (ADHD), according to a recent study.
Glyxambi is now available by prescription at pharmacies across the United States.
The FDA's advisory committee supports the approval of fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma in only adults.
The FDA is warning health care professionals and patients about OTC asthma products labeled as homeopathic remedies.
FDA laboratory analysis has confirmed that 3 products promoted as weight-loss supplements contain hidden drug ingredients with known risks.
The new test aids health care professionals and patients in determining whether a specific medication will address ADHD symptoms effectively.
Bristol-Myers Squibb is also clinically testing the potential of daclatasvir-based regimens in patients co-infected with HIV.
The agency is slated to review the new drug application within a 6-month timeframe.
Mylan Inc. has introduced 3 generic versions of existing drugs to the US market, including the first and only available intermediate dosages of transdermal fentanyl.