FDA Alerts

FDA Alerts
FDA Alerts
U.S. FDA overturns 30-year ban on blood donations by gay men
12/22/2015
<p>The U.S. Food and Drug Administration ruled on Monday that gay men can donate blood 12 months after their last sexual contact with another man, overturning a 30-year ban aimed at preventing the...
12/22/2015
Oncology
Oncology
FDA Roundup: New Options for Lung Cancer, von Willebrand Disease
12/14/2015
The FDA approved new options for non-small cell lung cancer, von Willebrand disease, and to treat overdoses of certain chemotherapies.
12/14/2015
FDA Alert
multiple myeloma
FDA Alert
FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Heavily Pretreated Multiple Myeloma
12/10/2015
Kate Young
The FDA has granted accelerated approval to linvoseltamab-gcpt, a BCMA-directed bispecific T-cell engager, offering a new option for patients with heavily pretreated relapsed or refractory multiple myeloma....
12/10/2015
FDA Alerts
FDA Alerts
FDA Panel Recommends Tighter Regulation for Codeine
12/10/2015
A joint FDA panel has recommended new restrictions for use of codeine in children.
12/10/2015
FDA Alerts
FDA Alerts
FDA Approves First Seasonal Flu Vaccine with Adjuvant, and More
11/25/2015
The FDA has approved new options for the treatment of seasonal influenza, squamous non-small cell lung cancer, and for the prevention of anthrax disease.
11/25/2015
FDA Alerts
FDA Alerts
What Is “Natural,” Anyway? FDA Edition
11/20/2015
You frequently see the word “Natural” on food packaging, but what does it mean? Probably not what you think it does. And the FDA has decided it’s time—maybe—to legally define the term, and enforce rules...
11/20/2015
FDA ALERT
fda
FDA ALERT
FDA Approves Interchangeable Biosimilar for Psoriatic Arthritis, Other Inflammatory Conditions
11/08/2015
Anthony Calabro, MA
The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.
11/08/2015
FDA ALERT
FDA ALERT
FDA Approves Interchangeable Biosimilar for Psoriatic Arthritis, Other Inflammatory Conditions
11/08/2015
Anthony Calabro, MA
The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.
11/08/2015
HIV
HIV
FDA Approves Once-Daily HIV Drug, New Option for Asthma
11/06/2015
The FDA has approved a new, daily, fixed-dose combination therapy for HIV treatment, and a new add-on treatment for severe, poorly-controlled asthma.
11/06/2015
Melanoma
Melanoma
FDA Approves Options for Melanoma, Soft Tissue Sarcomas
10/28/2015
The FDA has approved new options for the treatment of melanoma lesions, soft tissue sarcomas, and the rare metabolic disease, hypophosphatasia, that clinicians should be aware of.
10/28/2015