New Approvals – Page 15 – media

Galera Therapeutics Receives FDA Breakthrough Therapy Designation for GC4419 for the Reduction of Severe Oral Mucositis

Designation Based on Positive Results of Phase 2b Trial of GC4419 Severe Oral Mucositis Affects 70 Percent of Head & Neck Cancer Patients Receiving Radiotherapy
- Source: 4-traders
- 472
- March 2, 2018
FDA New Approvals severe oral mucositis SOM
FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

Vertex Pharmaceuticals Incorporated (VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor. SYMDEKO is Vertex’s third medicine approved to treat the underlying cause of CF. Vertex is ready to launch SYMDEKO and will begin shipping it to pharmacies in the United States this week.
- Source: finance.yahoo.
- 569
- March 1, 2018
cystic fibrosis FDA New Approvals SYMDEKO™
Lilly’s Verzenio bags third breast cancer nod

Eli Lilly’s Verzenio has been given another green light in the US for breast cancer, significantly expanding the drug’s treatment scope.
- Source: Pharmatimes
- 616
- March 1, 2018
breast cancer New Approvals
Japan Just Approved a New Drug That Can Kill the Flu Virus In Just One Day

As the worst flu season in a decade rages on, a potentially groundbreaking new drug that can kill the flu virus in just one day has won regulatory approval—in Japan.
- Source: Fortune
- 718
- February 28, 2018
flu New Approvals virus
AZ/MSD’s Lynparza wins new CHMP nod

AstraZeneca and MSD’s Lynparza is a step closer to being cleared in Europe as maintenance therapy for some patients with ovarian cancer.
- Source: pharmatimes
- 578
- February 28, 2018
AstraZeneca Chemotherapy MSD New Approvals ovarian cancer
Implanted continuous glucose sensor proven safe

Senseonics Holdings Inc has announced that people with diabetes using the Eversense® brand Continuous Glucose Monitoring Systems, in EMEA markets now have the option to invite others to remotely view their real-time glucose readings and alerts from anywhere.
- Source: globalbiotechinsights
- 722
- February 28, 2018
diabetes medical device mHealth New Approvals
Cognoa’s AI platform for autism diagnosis gets first FDA stamp

Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism — meaning the digital health startup is now positioned to submit an application for full FDA clearance.
- Source: Techcrunch
- 607
- February 27, 2018
AI autism FDA New Approvals
Novartis receives FDA approval for Cosentyx® label update to include moderate to severe scalp psoriasis

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
- Source: pharma.us.novartis
- 557
- February 13, 2018
Cosentyx® FDA New Approvals Scalp psoriasis
Sage Therapeutics Receives FDA Breakthrough Therapy Designation for SAGE-217 for the Treatment of Major Depressive Disorder

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.
- Source: finance.yahoo
- 757
- February 12, 2018
biopharmaceutical FDA major depressive disorder New Approvals
SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox

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).
- Source: investor.siga
- 609
- February 9, 2018
DNA FDA New Approvals TPOXX

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