FDA is re-examining the safety of a breakthrough Parkinson’s disease drug after reports of hundreds of deaths.
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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A new draft guidance document from FDA aims to help pharmaceutical manufacturers develop new medications to treat opioid use disorder.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
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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with compounded medications- including the 2012 fungal meningitis outbreak that led to 64 deaths-FDA is releasing a draft guidance that will determine which bulk drug substances outsourcing facilities can use to compound drugs.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.
As FDA considers new guidelines on pharmaceutical product marketing, a new study found that pharma makers may not be following current FDA ad regulations.
Over the past few months, several new diabetes treatments have been approved by FDA. Here are the top 3 novel drugs for diabetes.
A new FDA-approved drug offers new hope for patients with multidrug-resistant HIV-1 infection.
FDA approved the first direct-to-consumer test for three specific BRCA1/BRCA2 breast cancer gene mutations.
During the worst flu season in years, FDA is warning consumers about fraudulent and counterfeit flu and antiviral products from online pharmacies.
In a rare move, pharmaceutical manufacturers voluntarily recalled their drug to treat multiple sclerosis after reports of serious brain inflammation in patients.
The first radioactive drug to treat a certain type of cancer is among the top 3 new drug approvals for cancer. Here are the other top cancer drug approvals so far in 2018.
FDA said the manufacturer of dietary supplements containing kratom, a natural opioid used to treat opioid use disorder, agreed to destroy the supplements, and is again warning the public about kratom.
FDA should provide better education about biosimilar drugs on the agency’s web site dedicated to biosimilars, a patient advocacy group said.
FDA recently approved 3 major drugs to treat lung cancer, prostate cancer, and cystic fibrosis. Here are the top 3 new drug approvals.
A pharmacist organization is among the supporters of a new Medicare Part D proposal, which calls for a 7-day supply limit on opioid prescriptions.
Due to the increased use of illicit fentanyl mixed with heroin and used in counterfeit prescription drugs, the DEA placed all illicit fentanyl analogues not already regulated by the Controlled Substances Act into Schedule I.
FDA approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of ceftazidime and avibactam (Avycaz) to include 2 types of pneumonia.
FDA is adding a Boxed Warning, its most prominent warning, on a liver disease medicine.
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