The manufacturer of bevacizumab (Avastin), snagged FDA approval for yet another type of cancer.
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FDA approved the first biosimilar to Neulasta, as well as a new combination treatment for osteoarthritis pain and hypertension and a new drug to treat chronic lymphocytic leukemia.
The manufacturer of two cancer drugs hiked the price on the medicines despite President Donald Trump’s new plan to lower drug prices.
FDA is warning that 2 liquid-filled intragastric balloon systems used to treat obesity are causing deaths in some patients
FDA’s new guidances on Risk Evaluation and Mitigation Strategy (REMS) requirements aims to help generic and biosimilar drugs get to market faster.
FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.
While the pharmaceutical industry has made tremendous advances in new drug development this year, FDA has also had to remove drugs from the market or investigate problem drugs. Here are the top 3 drug warnings and problems so far in 2018.
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The first smallpox treatment, being developed for the United States government in the case of a bioterrorism attack, could be available as early as August.
A combination cancer treatment has been expanded to include treating both melanoma and anaplastic thyroid cancer (ATC).
FDA is re-examining the safety of a breakthrough Parkinson’s disease drug after reports of hundreds of deaths.
After FDA approved the first epinephrine injection specifically for infants and toddlers last year, the drug is now on the market.
A new draft guidance document from FDA aims to help pharmaceutical manufacturers develop new medications to treat opioid use disorder.
FDA approved a new treatment for non-small cell lung cancer, as well as drugs to treat chronic immune thrombocytopenia and a rare form of childhood rickets.
FDA is permitting marketing of the first medical device that uses artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy.
FDA approved a new indication for Exparel Bupivacaine Liposome injectable suspension (Exparel, Pacira) for use as a nerve block to produce post-surgical regional analgesia following shoulder surgery in adults.
After US Surgeon General Jerome M. Adams, MD, MPH, urged more Americans to carry naloxone to reverse opioid overdoses, organizations and medical experts praised the decision.
A new deal between pharma giants AbbVie and Samsung Bioepis is designed to postpone competition against a biosimilar to Humira until 2023.
FDA okayed the marketing of a new continuous glucose monitoring system for diabetics-the first to be used as part of an integrated system with other compatible medical devices and electronic interfaces.
FDA’s approval of a new combination treatment for patients with classical Hodgkin lymphoma (cHL) is the first new advanced treatment for the disease in 40 years
Due to problems with compounded medications- including the 2012 fungal meningitis outbreak that led to 64 deaths-FDA is releasing a draft guidance that will determine which bulk drug substances outsourcing facilities can use to compound drugs.
President Donald Trump was expected to announce a new plan to combat the opioid crisis, even as a recent study found that prescription opioids were not as effective as over-the-counter medications for pain management.
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