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  • Namzaric gets FDA approval for expanded label

    SILVER SPRING, Md. — Allergan and Adamas Pharmaceuticals on Tuesday announced an expanded label for their Namzaric (memantine and donepezil hydrochlorides). It can now be used by patients with moderate to severe Alzheimer’s disease. 
     
    Patients currently stabilized on Aricept (donepezil HCL, 10 mg) can begin combination therapy with Namzaric. 
     

  • FDA expands Prezista indication

    SILVER SPRING, Md. — The Food and Drug Administration has approved a bew indication for Janssen Therapeutics’ Prezista (darunavir), the company announced Monday. Prezista, a treatment for HIV-1 in adults and children older than 3 years of age, can now be used by pregnant women with HIV. 
     

  • Industry orgs respond to PDUFA reauthorization letter

    SILVER SPRING, Md. and WASHINGTON — The Food and Drug Administration on Friday released a document containing details — procedures and performance goals — for the Prescription Drug User Fee Act (PDUFA) reauthorization, or PDUFA VI. 
     

  • Cefaly Technology relaunches Rx-only migraine wearable

    NEW YORK - Cefaly Technology on Monday relanuched its "wearable" for the treatment of migraines after undergoing a massive makeover, the company announced.

    Cefaly I, which gained popularity for its unique headband-like shape, is now three-quarters its size, fits in the palm of a person's hand, is rechargeable, uses magnets to stay in place and allows patients more control over the intensity of their daily session. The new Cefaly II, is available exclusively in the United States; it will become available next in Europe in September.

  • Report: FDA panel backs Amgen’s Humira biosimilar

  • Protein Sciences: FDA approves 2016/17 formulation of Flublok

    MERIDEN, Conn. - Protein Sciences Corporation on Tuesday announced that FDA has approved the 2016/17 formulation of Flublok influenza vaccine.   

    FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August.     

  • FDA approves Shire’s Xiidra

    SILVER SPRING, Md. — The Food and Drug Administration has approved Shire’s Xiidra (lifitegrast ophthalmic solution, 5%), the company announced Tuesday. Xiidra is twice-daily eyedrop solution indicated to treat signs and symptoms of dry eye, which affects an estimated 16 million adults in the U.S. The drug is the first approval from Shire’s ophthalmics pipeline
     

  • FDA approves wearable delivery system for Amgen’s Repatha

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug delivery device for Amgen’s Repatha (evolocumab), the company announced Monday. The Pushtronex system is an on-body infusor with a pre-filled cartridge with a 420-mg monthly dose of the cholesterol-lowering drug, one of two new drugs in a class of PCSK9 inhibitors. 
     
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