Krystle Vermes

Single-tablet combination was previously granted two breakthrough therapy designations.

Pharmacists should be aware that a clopidogrel tablet found in a bottle of hydrochlorothiazide tablets has prompted a product recall.

The FDA has granted priority review to Merck's chronic hepatitis C virus (HCV) treatment candidate grazoprevir/elbasvir.

Novel oral soluble film is indicated to prevent highly and moderately emetogenic chemotherapy-induced nausea and vomiting.

Galena Biopharma had introduced ondansetron (Zuplenz) to the US market.

Generic Pulmicort Respules is approved for the treatment of asthma and to serve as prophylactic therapy in children aged 12 months to 8 years.

Sandoz has launched a generic version of AstraZeneca's asthma drug Pulmicort Respules in the US market.

Treatment regimen was previously approved for 12 weeks in patients without cirrhosis or 24 weeks in those with cirrhosis.

A pharmacy in Washington is recalling unexpired human and veterinary compounded drugs due to concerns about their sterility.

Kyprolis treats patients who received at least 2 prior therapies and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Janssen is asking the FDA to update the label of its once-daily hepatitis C virus (HCV) drug simeprevir (Olysio).

The FDA has expanded the indication for Amgen's carfilzomib (Kyprolis) in combination with lenalidomide (Revlimid) and dexamethasone to treat patients with relapsed multiple myeloma who have received at least 1 prior therapy.

Roche has launched a diagnostic assay designed to identify Human T-lymphotropic virus I/II (HTLV-I/II) in donated blood or routine samples.

The first prosthetic device for adults with above-the-knee amputations who cannot use a conventional leg prosthesis is now authorized for use in the United States.

Baxter International is recalling 2 lots of intravenous solutions due to the presence of insects.

Another generic version of the injectable anticoagulant bivalirudin (Angiomax) has been launched by Hospira.

The FDA has received Akorn's Paragraph IV filing seeking approval for its generic version of Allergan's Restasis.

A mobile app designed for health care professionals and caregivers of diabetics who may need glucagon treatment is now available for both Android and Apple devices.

Generic versions of Actavis's Namenda treatment for moderate-to-severe Alzheimer's dementia have been launched by Dr. Reddy's Laboratories and Mylan.

The FDA recently approved Veloxis Pharmaceuticals' tacrolimus extended-release tablets to prevent organ rejection in kidney transplant patients.

Sandoz has launched a generic version of the injectable anticoagulant, bivalirudin (Angiomax), following a completed supply and distribution deal with The Medicines Company.

Drug treats cutaneous manifestations of t-cell lymphoma.

The first generic version of Valeant's bexarotene (Targretin) is now available from Mylan.

The FDA has notified health care professionals about a Class I recall of Maquet's FLOW-i Anesthesia System, due to complaints of a dislodged part preventing ventilation.

Xeljanz treat adults with moderate to severe active RA who have had an inadequate response or intolerance to methotrexate.

The FDA is warning consumers who purchase diazepam (Valium) online that the anti-anxiety drug could be counterfeit.

The once-daily, single-tablet regimen is the third tenofovir alafenamide-based HIV treatment from Gilead Sciences.

The FDA is reviewing a once-daily formulation of Pfizer's tofacitinib citrate (Xeljanz) for rheumatoid arthritis (RA).

Gilead Sciences is seeking FDA approval for its third tenofovir alafenamide-based HIV treatment.

The FDA is taking enforcement actions against manufacturers and distributors of unapproved prescription eardrops.