Christine Blank
FDA approves generic Tamiflu, plus 2 other new drugs
FDA approves generic Tamiflu, plus 2 other new drugs
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.
Cholesterol drug misbranded, company pleads guilty
Cholesterol drug misbranded, company pleads guilty
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 alters stance on opioid addiction drugs
FDA alters stance on opioid addiction drugs
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
FDA okays biosimilar for several cancers
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
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
FDA warns about deaths in cancer drug trials
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
Blockbuster diabetes drug earns heart indication
A top-selling diabetes drug has gained a cardiovascular indication from FDA.
Will new biosimilars hurt blockbuster autoimmune drug?
Will new biosimilars hurt blockbuster autoimmune drug?
New biosimilars may harm the sales of this autoimmune blockbuster.
FDA okays targeted leukemia treatment
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
FDA eyes opioids in kids' medicines
An FDA committee will review prescription opioid products containing hydrocodone or codeine to treat coughs in children.

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