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.
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).
Gilead Sciences, Inc. on February 7 announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
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.
A second patient has been treated in a historic gene editing study in California, and no major side effects or safety issues have emerged from the first man’s treatment nearly three months ago, doctors revealed Tuesday.
Emaptica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.
Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
your submission has already been received.
Please enter a valid Email address！
The most relevant industry news & insight will be sent to you every two weeks.