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- Page 74
FDA: Risk of blindness from compounded eye drug
November 13, 2017
FDA warns that this compounded eye drug could lead to a disease that causes blindness.
First Zika test for blood donations wins nod from FDA
November 13, 2017
ISMP issues insulin pen warning after patient death
November 13, 2017
More education is needed for diabetic patients after a patient died from incorrectly using an insulin pen, according to a new warning from the Institute for Safe Medication Practices.
New diabetes drug set to rival Trulicity
November 13, 2017
If it is approved by FDA, an investigational drug to improve glycemic control in patients with type 2 diabetes will likely be a strong competitor to Eli Lilly’s dulaglutide (Trulicity).
Shingles vaccine wins approval
November 13, 2017
FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.
Activists: drugmakers, distributors liable for opioids abuse
November 13, 2017
Soon after President Donald Trump declared the opioid abuse crisis a “public health emergency," shareholder activist groups said they aim to hold drug manufacturers and distributors liable for their part in the crisis.
FDA advisors recommend 2 opioid use disorder drugs
November 7, 2017
Two opioid use disorder drugs have been recommended for approval by FDA committees.
FDA okays unique injectable for type 2 diabetics
October 24, 2017
FDA approved a new once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.
Drug shortages likely after hurricanes
October 16, 2017
FDA Commissioner Scott Gottlieb, MD, said that the United States is likely to see shortages on certain drugs because after Hurricanes Irma and Maria knocked out power to the islands.
New drug offers hope to advanced breast cancer patients
October 2, 2017
FDA approved a new treatment for certain breast cancer patients who are not responding to treatment.
Novel device helps diabetics avoid stress linked to glucose testing
October 2, 2017
FDA approved the first continuous glucose monitoring system that allows for diabetes treatment decisions without requiring a fingerstick.
Cholesterol drug misbranded, company pleads guilty
September 25, 2017
Pharma maker pleads guilty that one of its major drugs was misbranded in a federal court case brought by FDA and the US Department of Justice.
FDA approves generic Tamiflu, plus 2 other new drugs
September 25, 2017
FDA approved the first generic version of oseltamivir phosphate (Tamiflu, Roche) for oral suspension to treat influenza A and B, plus 2 other noteworthy therapies.
FDA alters stance on opioid addiction drugs
September 25, 2017
FDA is advising that these 2 opioid addiction medications should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system.
FDA okays biosimilar for several cancers
September 19, 2017
While FDA has approved a handful of biosimilar drugs, the agency just approved the first biosimilar that treats a variety of types of cancer.
FDA warns Pfizer’s Meridian over EpiPen flaws
September 12, 2017
FDA warned about an injunction or seizure if Meridian Medical Technologies, a division of Pfizer, does not correct its problems with the EpiPen (epinephrine auto-injector).
FDA warns about deaths in cancer drug trials
September 12, 2017
An increased risk of deaths for patients in clinical trials receiving this cancer drug and two other drugs led FDA to stop the clinical trials.
Blockbuster diabetes drug earns heart indication
August 29, 2017
A top-selling diabetes drug has gained a cardiovascular indication from FDA.
Will new biosimilars hurt blockbuster autoimmune drug?
August 29, 2017
New biosimilars may harm the sales of this autoimmune blockbuster.
FDA okays targeted leukemia treatment
August 22, 2017
FDA approved a targeted new drug to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
FDA eyes opioids in kids' medicines
August 21, 2017
An FDA committee will review prescription opioid products containing hydrocodone or codeine to treat coughs in children.
Groups praise lawsuit against Walgreens, CVS
August 15, 2017
Pharmacy and medical organizations lauded a new class action lawsuit against CVS Health and Walgreens, alleging the two pharmacy chains colluded with pharmacy benefit managers (PBMs) to drive up the cost of generic drugs.
FDA warns about contaminated drugs, dietary supplements
August 15, 2017
FDA warned consumers and health care professionals not to use a certain brand of drugs and dietary supplements that are contaminated.
DEA wants to slash opioid production
August 7, 2017
The Drug Enforcement Administration wants to slash the production of opioid painkillers by 20% in 2018.
FDA approves novel leukemia, hepatitis C drugs
August 4, 2017
FDA approved the first treatment for patients with a certain type of acute myeloid leukemia, as well as 2 new drugs to treat hepatitis C.
Popular insulin meets target in real-world study
By
Erin Johanek, PharmD, RPh
July 14, 2017
Novo Nordisk’s DEVOTE study reveals interesting findings.
New universal companion diagnostic paves the way for precision oncology
By
Erin Johanek, PharmD, RPh
July 14, 2017
FDA approves new diagnostic test for non-small cell lung cancer.
FDA approves Bayer’s Bluetooth-enabled auto-injector for multiple sclerosis
July 5, 2017
FDA has approved a supplemental Biologics License Application (sBLA) for Bayer’s myBETAapp and BETACONNECT Navigator for multiple sclerosis (MS) patients
New antibiotic approved for acute bacterial skin infections
By
Erin Johanek, PharmD, RPh
July 5, 2017
FDA approved the use of a new fluoroquinolone antibiotic to treat ABSSSI.
FDA to drug maker: Pull opioid pain drug
By
Erin Johanek, PharmD, RPh
July 1, 2017
Potential public health consquences prompts FDA to request removal of opioid pain medication.
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