SPOTLIGHT -
Top 3 new drugs to treat rare diseases
FDA recently approved a new treatment for 2 rare types of non-Hodgkin lymphomas, as well as a new drug to treat hereditary angiodema and 1 for Fabry disease. Here are the top three new drugs to treat rare diseases.
FDA warns CBD supplement maker
While FDA approved the first drug containing cannibidiol (CBD), it is cracking down on certain other CBD products marketed as supplements.
Novel gene-silencing drug holds promise for this rare disease
FDA clears first-of-its-kind gene therapy for rare disease.
Generic EpiPen poised to alleviate shortages
While FDA approved the first generic version of epinephrine (EpiPen and EpiPen Jr, Mylan), the new product is not yet on the market.
Major PBM’s formulary exclusions cause concerns
Pharmaceutical industry observers are concerned about some of the drugs that were slashed from Express Scripts’ 2019 National Preferred Formulary.
First drug approved under streamlined generic approval process
The first medication approved by FDA as part of an expedited generic drug program is one that has been in short supply.
FDA okays radiation drug for ultra-rare cancers
FDA okayed iobenguane I 131 (Azedra, Progenics Pharmaceuticals) injection for IV use to treat rare tumors of the adrenal gland.
Novel, single-tablet HIV-1 treatment available
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.
Breast cancer drug first to get nod in FDA accelerated approval program
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.
First-in-class targeted drug approved for acute myeloid leukemia
Broader indication for prostate cancer drug could net billions of dollars
FDA’s approval of an expanded indication for a prostate cancer drug could net 2 pharmaceutical manufacturers billions of dollars.
Cancer risk found with common blood pressure med
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.
FDA clears first chronic drooling treatment
FDA okayed the first treatment for chronic sialorrhea, or excessive drooling, in adult patients.
Cancer in the news: Three stories you can’t miss
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 clears novel device for severe emphysema
FDA approved a novel device to treat breathing difficulty associated with severe emphysema.
New targeted melanoma combo drug available
A combination melanoma treatment that was just approved by FDA is available through select specialty pharmacies.
FDA approves first cannabis-based drug for rare forms of epilepsy
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.
FDA approves first long-term implantable glucose-monitoring system
Avastin gains approval for another cancer type
The manufacturer of bevacizumab (Avastin), snagged FDA approval for yet another type of cancer.
Manufacturer blocks sale of generic Suboxone
FDA backs new biosimilar, plus 2 more approvals
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.
Cancer drug prices rise despite Trump plan
The manufacturer of two cancer drugs hiked the price on the medicines despite President Donald Trump’s new plan to lower drug prices.
FDA: Deaths linked to obesity devices
FDA is warning that 2 liquid-filled intragastric balloon systems used to treat obesity are causing deaths in some patients
How FDA is accelerating generics, biosimilars to market
FDA’s new guidances on Risk Evaluation and Mitigation Strategy (REMS) requirements aims to help generic and biosimilar drugs get to market faster.
FDA wants certain OTC teething gels off the market
FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.
Top 3 drug alerts of 2018
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.
FDA approves first factor Xa inhibitor antidote
Top 3 new drug approvals
Breakthrough childhood MS drug okayed
Pharmacy chains praise Trump drug pricing plan
