FDA clears first-of-its-kind gene therapy for rare disease.
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While FDA approved the first generic version of epinephrine (EpiPen and EpiPen Jr, Mylan), the new product is not yet on the market.
Pharmaceutical industry observers are concerned about some of the drugs that were slashed from Express Scripts’ 2019 National Preferred Formulary.
The first medication approved by FDA as part of an expedited generic drug program is one that has been in short supply.
FDA okayed iobenguane I 131 (Azedra, Progenics Pharmaceuticals) injection for IV use to treat rare tumors of the adrenal gland.
FDA recently approved the first and only complete darunavir-based single-tablet regiment to treat HIV-1 in treatment-naïve and certain virologically suppressed adults.
A breast cancer drug is the first approval from FDA in 2 new pilot programs that make the development and review of cancer drugs more efficient.
FDA’s approval of an expanded indication for a prostate cancer drug could net 2 pharmaceutical manufacturers billions of dollars.
Pharma makers are voluntarily recalling several drugs containing this active ingredient, used to treat high blood pressure and heart failure, since they may contain a carcinogen.
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FDA okayed the first treatment for chronic sialorrhea, or excessive drooling, in adult patients.
A pharma maker is under fire for raising prices on its cancer drugs. Meanwhile, there were two major cancer drug approvals in June. Here are the top 3 cancer news articles in the past month.
FDA approved a novel device to treat breathing difficulty associated with severe emphysema.
A combination melanoma treatment that was just approved by FDA is available through select specialty pharmacies.
FDA’s approval of a cannabidiol (CBD) medicine to treat seizures associated with 2 severe forms of epilepsy is a positive sign for other CBD drugs under development.
The manufacturer of bevacizumab (Avastin), snagged FDA approval for yet another type of cancer.
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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