CLINICAL ROLE -
Orphan Rapid Infusion Cancer Drug Under FDA Review
The FDA is considering approval for a liquid bendamustine hydrochloride rapid infusion product.
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Combination HIV Treatment Awaits FDA Action
TAF shows signs of improved renal and bone parameters compared with Viread in clinical trials.
New Liletta IUD Launched in US
The levonorgestrel-releasing intrauterine system can prevent pregnancy for up to 3 years.
Gilead Sciences is seeking FDA approval for emtricitabine/tenofovir alafenamide.
Dry Eye Drug Under FDA Priority Review
The FDA has granted priority review to Shire's lifitegrast treatment.
FDA Reviews Resubmissions for Novo Nordisk's Long-Acting Insulin
The FDA refused to approve Novo Nordisk's ultra-long-acting insulin treatments 2 years ago.
FDA Grants Breakthrough Designations to Merck's Hepatitis C Candidate
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.
Pediatric Data Needed for Adult ADHD Drug Approval
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.
First Generic Generess Launched in US
Mylan has launched the first generic version of the chewable contraceptive.
Actavis Files for Generic Letairis Approval
Actavis is seeking FDA approval for its generic version of Gilead Sciences' Letairis pulmonary arterial hypertension treatment.
FDA Outlines Guidance for Abuse-Deterrent Opioids
The FDA has outlined the type of studies opioids need to complete to win approval for abuse-deterrence.
Shire's Hypocalcemia Drug Launches in US
Shire's self-administered parathyroid hormone (Natpara) is now available in the United States.
More Generic Versions of Hypertension Drug Hit US Market
Teva, Mylan, and Sandoz announced the US launches of their generic equivalents to Novartis's Exforge.
Amgen Seeks Expanded Use for Multiple Myeloma Drug
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.
Novo Nordisk to Resubmit Rejected Insulin Candidates to FDA
The FDA refused to approve the ultra-long-acting insulin treatments 2 years ago.
Non-Alcohol Docetaxel Formula Awaits FDA Decision
Teikoku Pharma USA has submitted a New Drug Application to the FDA for the product.
Improved Intraocular Lens Delivery System Released
The enhanced system gives eye care professionals the ability to safely deliver an intraocular lens through incisions as small as 2.2 mm.
FDA Investigation into Schizophrenia Drug Deemed Inconclusive
Zyprexa Relprevv's label and recommended use remain unchanged.
New ADHD Drug Dosing Option Now Available
Shire's ADHD treatment, lisdexamfetamine dimesylate (Vyvanse), is now available in a 10-mg titration dose.
ADHD Symptoms Prevalent Among Epileptic Adults
Nearly one in 5 adults with epilepsy show symptoms of attentiondeficit/ hyperactivity disorder (ADHD), according to a recent study.
Newly Approved Type 2 Diabetes Treatment Now Available in Pharmacies
Glyxambi is now available by prescription at pharmacies across the United States.
FDA Panel Recommends Asthma Treatment Approval for Adults Only
The FDA's advisory committee supports the approval of fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma in only adults.
OTC Asthma Products Labeled Homeopathic Pose Potential Health Risks
The FDA is warning health care professionals and patients about OTC asthma products labeled as homeopathic remedies.
FDA Warns of Risky Drugs in Weight-Loss Supplements
FDA laboratory analysis has confirmed that 3 products promoted as weight-loss supplements contain hidden drug ingredients with known risks.
Genetic ADHD Test May Inform More Effective Treatment
The new test aids health care professionals and patients in determining whether a specific medication will address ADHD symptoms effectively.
FDA Accepts Combination Hepatitis C Treatment Application for Review
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 Expands Generic Fentanyl Patch Doses
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.