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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A new draft guidance document from FDA aims to help pharmaceutical manufacturers develop new medications to treat opioid use disorder.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.
Groups, experts praise naloxone advisory
Groups, experts praise naloxone advisory
April 10, 2018
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.
New deal staves off Humira biosimilar competition
New deal staves off Humira biosimilar competition
April 9, 2018
A new deal between pharma giants AbbVie and Samsung Bioepis is designed to postpone competition against a biosimilar to Humira until 2023.
FDA approves first-of-its kind diabetes management device
FDA approves first-of-its kind diabetes management device
March 29, 2018
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 approves revolutionary blood cancer treatment
FDA approves revolutionary blood cancer treatment
March 26, 2018
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
Compounding facilities face new FDA regs
Compounding facilities face new FDA regs
March 26, 2018
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.
Are opioids better than nonopioids to improve pain?
Are opioids better than nonopioids to improve pain?
March 20, 2018
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.
DTC drug ads don't show risks, study says
DTC drug ads don't show risks, study says
March 20, 2018
As FDA considers new guidelines on pharmaceutical product marketing, a new study found that pharma makers may not be following current FDA ad regulations.
Top 3 novel diabetes treatments
Top 3 novel diabetes treatments
March 19, 2018
Over the past few months, several new diabetes treatments have been approved by FDA. Here are the top 3 novel drugs for diabetes.
FDA approves breakthrough drug for HIV patients with dwindling options
FDA approves breakthrough drug for HIV patients with dwindling options
March 13, 2018
A new FDA-approved drug offers new hope for patients with multidrug-resistant HIV-1 infection.
First direct-to-consumer test for breast cancer risk hits market
First direct-to-consumer test for breast cancer risk hits market
March 12, 2018
FDA approved the first direct-to-consumer test for three specific BRCA1/BRCA2 breast cancer gene mutations.
FDA warns about fraudulent flu products
FDA warns about fraudulent flu products
March 5, 2018
During the worst flu season in years, FDA is warning consumers about fraudulent and counterfeit flu and antiviral products from online pharmacies.
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