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All News - Page 70

Breast cancer drug first to get nod in FDA accelerated approval program
Breast cancer drug first to get nod in FDA accelerated approval program
Breast cancer drug first to get nod in FDA accelerated approval program
July 24, 2018
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.
Broader indication for prostate cancer drug could net billions of dollars
Broader indication for prostate cancer drug could net billions of dollars
Broader indication for prostate cancer drug could net billions of dollars
July 16, 2018
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
Cancer risk found with common blood pressure med
Cancer risk found with common blood pressure med
July 16, 2018
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 clears first chronic drooling treatment
FDA clears first chronic drooling treatment
July 10, 2018
FDA okayed the first treatment for chronic sialorrhea, or excessive drooling, in adult patients.
Cancer in the news: Three stories you can’t miss
Cancer in the news: Three stories you can’t miss
Cancer in the news: Three stories you can’t miss
July 9, 2018
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 clears novel device for severe emphysema
July 2, 2018
FDA approved a novel device to treat breathing difficulty associated with severe emphysema.
New targeted melanoma combo drug available
New targeted melanoma combo drug available
July 2, 2018
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 approves first cannabis-based drug for rare forms of epilepsy
FDA approves first cannabis-based drug for rare forms of epilepsy
June 26, 2018
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.
Avastin gains approval for another cancer type
Avastin gains approval for another cancer type
June 18, 2018
The manufacturer of bevacizumab (Avastin), snagged FDA approval for yet another type of cancer.
FDA backs new biosimilar, plus 2 more approvals
FDA backs new biosimilar, plus 2 more approvals
June 11, 2018
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
Cancer drug prices rise despite Trump plan
Cancer drug prices rise despite Trump plan
June 11, 2018
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: Deaths linked to obesity devices
June 4, 2018
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
How FDA is accelerating generics, biosimilars to market
How FDA is accelerating generics, biosimilars to market
June 4, 2018
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 wants certain OTC teething gels off the market
May 24, 2018
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
Top 3 drug alerts of 2018
May 24, 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.
First smallpox treatment on the horizon
First smallpox treatment on the horizon
May 7, 2018
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.
FDA approves first combo treatment for BRAF-positive anaplastic thyroid cancer
FDA approves first combo treatment for BRAF-positive anaplastic thyroid cancer
May 7, 2018
A combination cancer treatment has been expanded to include treating both melanoma and anaplastic thyroid cancer (ATC).
FDA issues guidance on opioid use disorder meds
FDA issues guidance on opioid use disorder meds
April 24, 2018
A new draft guidance document from FDA aims to help pharmaceutical manufacturers develop new medications to treat opioid use disorder.
New lung cancer drug gains approval, plus 2 more
New lung cancer drug gains approval, plus 2 more
April 24, 2018
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 approves landmark AI device to detect diabetic eye disease
FDA approves landmark AI device to detect diabetic eye disease
April 17, 2018
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 approves non-opioid drug for shoulder surgery
FDA approves non-opioid drug for shoulder surgery
April 17, 2018
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.
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