The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.1-3 The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.6
Sage Therapeutics (SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to SAGE-217 for the treatment of major depressive disorder (MDD). This is the second Breakthrough Therapy designation granted to Sage since 2016.
A San Francisco, California-based medical device startup, Zenflow, has announced a $31.4 million Series A financing round to further its minimally-invasive approach to treating benign prostatic hyperplasia (BPH) or enlarged prostate.
SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its oral formulation of TPOXX® (tecovirimat).
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
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