The US Food and Drug Administration (FDA) has unveiled a 90-day plan to address the backlog of around 200 orphan drug designation requests that have been pending for more than 120 days. The regulatory body aims to complete reviews of all requests in this category by September 21st 2017 and plans to...

A new once-daily medication to treat patients with attention deficit and hyperactivity disorder (ADHD) aged 13 and above has been approved by the US Food and Drug Administration (FDA). Shire first filed an application to market the drug in US pharmacies in 2006, but was required to conduct...

A new treatment for adults with acute bacterial skin and skin-structure infections has been granted approval by the US Food and Drug Administration (FDA). Baxdela (delafloxacin) is available as an intravenous formulation and in oral form and was developed by Melinta Therapeutics. It is a...

Patients could soon see an influx of cheaper generic medication onto the market following the US Food and Drug Administration's (FDA) unveiling of new steps to stimulate drug competition and improve access to generic drugs.  It published a list of branded off-patent medication currently...

Keeping up to date with vaccinations and immunization records plays an important role in staying one step ahead of infectious diseases. It is particularly important in children and infants, with modern vaccines providing protection against a number of illnesses that can prove dangerous and...

A cheaper alternative to the EpiPen will soon be available in pharmacies for patients suffering from severe allergies. The US Food and Drug Administration (FDA) approved a new epinephrine pre-filled syringe (PFS) called Symjepi, which is manufactured Adamis Pharmaceuticals...

Over-the-counter (OTC) medication offers quick and convenient relief for a whole range of symptoms, conditions and ailments, but with a bewildering variety of products available in pharmacies and drugstores, making an informed decision about OTC medicine can be a challenge for consumers. Should you...

The US Food & Drug Administration (FDA) has approved the first generic version of Truvada (emitricitabine/tenofovir disoproxil fumarate), a medication used in the treatment and prevention of HIV infection. Gilead Science's branded drug Truvada is a combination of the antiretroviral drugs...

Pharmaceutical firm Bristol-Myers Squibb has announced a voluntary recall of one lot of Eliquis (apixaban) 5mg tablets following a consumer complaint that their bottle contained 2.5mg tablets. The affected lot is a 60-count bottle containing 5mg tablets of the medication and it was distributed...

Nevada could become the first state in the United States. to allow all residents to buy into the Medicaid program, no matter what their income level. The state's legislature passed the bill earlier this month, but the final decision rests with Republican governor Brian Sandoval, who has the power...

Endo International is reviewing a request from the US Food & Drug Administration (FDA) to remove the opioid pain medication Opana ER (oxymorphone hydrochloride extended release) from the market. The government body's Drug Safety Risk Management and Anesthetic and Analgesic Drug Products...

The US Food & Drug Administration (FDA) has approved a generic form of Eli Lilly and Company's Strattera (atomoxetine), used to treat patients with attention-deficit/hyperactivity disorder (ADHD). The generic non-stimulant ADHD medication will be brought to market by Apotex Inc., Teva...

A Phase III OlympiAD trial of Lynparza (olaparib) tablets for treating patients with HER2-negative gBRCA-mutated metastatic breast cancer has yielded positive results with a "statistically-significant and clinically-meaningful improvement in progression-free survival". Pharmaceutical firm...

Many patients with chronic obstructive pulmonary disease (COPD) who have Medicare Part D struggle to pay for medication and inhalers, it has been suggested. A report published in the Journal of the American Medical Association (JAMA) revealed one in nine Medicare beneficiaries have COPD. The...

A topical ocular cetirizine formulation has gained US Food & Drug Administration (FDA) New Drug Application approval for treating allergic conjunctivitis. Zerviate (cetirizine ophthalmic solution 0.24%) was developed by ophthalmic research and development company Nicox. The new topical...

Lupin Pharmaceuticals has announced the voluntary recall of a batch of Mibelas 24 Fe (norethindrone acetate and ethinylestradiol) 1mg/0.02mg chewable tablets and ferrous fumarate 75 mg) tablets. The medication is a oral contraceptive and taking the tablets in an incorrect order may place users at...

Late spring and early summer are the toughest times of the year for many patients suffering from grass allergies and hay fever. Grasses and plants release grains of pollen to fertilize other plants, but many people struggle with allergic reactions to these pollens. These cause uncomfortable...

The US Food & Drug Administration's (FDA) decision to approve a medication to treat patients whose cancer has a specific genetic feature, or biomarker, has been hailed as an "important first" in the fight against the disease. Keytruda (pembrolizumab) is a monoclonal antibody already in use to...

Sanofi and Regeneron Pharmaceuticals have gained approval from the US Food & Drug Administration (FDA) for use of Kevzara (sarilumab) for treating patients with rheumatoid arthritis. The prescription medication will be available to patients who do not respond to, or are intolerant, to disease...

An estimated 119 million Americans over the age of 12 take prescription medication, according to figures from the National Survey on Drug Use and Health. However, many struggle with the rising cost of their medicine, even those with health insurance to help them afford the required...