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  • Janssen’s Invokamet gets expanded indication from FDA

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved an expanded indication for Janssen Pharmaceuticals’ diabetes medication Invokamet (canagliflozin and metformin HCl). The drug has been approved as a first-line treatment for adults with type 2 diabetes who aren’t being treated with either canagliflozin or metformin. 
     

  • FDA approves Seqirus’ Flucelvax Quadrivalent flu vaccine

    SILVER SPRING, Md. — The Food and Drug Administration has approved Seqirus’ Flucelvax Quadrivalent, the first four-strain cell structure-derived inactivated influenza vaccine for adults and children over 4 years of age, the company announced Monday. 
     
    The quadrivalent vaccine covers two strains each of influenza A and influenza B and is derived from a cell culture — the same cell culture technology the company used in its first product Flucelvax. 
     

  • Galderma launches new Mirvaso Gel pump dispenser

    FORTH WORTH, Texas — Galderma Laboratories announced Thursday that it had launched a new pump dispenser system for its Mirvaso (brimonidine) topical gel. The gel treats facial redness associated with rosacea and the new pump dispenses a consistent dose with each use. 
     

  • FDA issues safety alert for diabetes meds Invokana, Invokamet

    SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a safety alert about the diabetes medicine canagliflozin (Invokana, Invokamet). An ongoing clinical trial has found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the drug.
     
    Although the FDA has not determined whether canagliflozin increases the risk of leg and foot amputations, it is currently investigating the issue and will update the public when it has more information.
     

  • Pfizer to acquire Anacor Pharmaceuticals

    NEW YORK — Pfizer announced Monday that it would be acquiring Anacor Pharmaceuticals for about $5.2 billion, a transaction that has been approved by both companies’ boards of directors. Currently, Anacor’s flagship asset, crisaborole — a non-steroidal topical PDE inhibitor with anti-inflammatory properties — is currently awaiting review from the Food and Drug Administration to treat mild to moderate eczema. 
     

  • FDA approves Eisai’s Lenvima for advanced renal cell carcinoma

    SILVER SPRING, Md. — The Food and Drug Administration on Friday approved a new indication for Eisai’s Lenvima (lenvatinib). The multiple receptor tyrosine kinase inhibitor has been approved to treat advanced renal cell carcinoma (RCC) in combination with everolimus in patients previously treated with an anti-angiogenic therapy. 
     

  • FDA warns of serious side effects from certain antibiotics

    SILVER SPRING, Md. — The Food and Drug Administration issued a safety message late last week concerning the potential for serious side effects associated with fluoroquinolone antibiotics. 
     

  • MD Labs' Rxight advances President's Precision Medicine Initiative

    WASHINGTON – In an effort to expand upon President Barack Obama’s Precision Medicine Initiative and explore innovative ways to individualize patient care, representatives from MD Labs recently met with senior leadership at the White House Office of Science and Technology Policy.
     
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