Search Results for “FDA” – Page 73 – media

FDA Clears First Device to Help Curb Opioid Cravings

The US Food and Drug Administration (FDA) has approved a device designed to reduce the symptoms of opioid withdrawal.
- Source: medscape
- 567
- November 16, 2017
cranial nerves FDA New Approvals opioid stimulator
AstraZeneca-FASENRA Gets US FDA Approval For Severe Eosinophilic Asthma

AstraZeneca and its global biologics research and development arm, MedImmune, said Tuesay that the US Food and Drug Administration has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
- Source: businessinsider
- 561
- November 15, 2017
asthma eosinophilic Market Views New Approvals
Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)

Seattle Genetics, Inc. (SGEN) announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
- Source: finance.yahoo
- 466
- November 13, 2017
ADCETRIS anaplastic large cell lymphoma FDA
Dynavax Announces FDA Approval of HEPLISAV-B™ for Prevention of Hepatitis B in Adults

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
- Source: investors.dynavax
- 559
- November 13, 2017
FDA hepatitis B Heplisav-B
Merck Receives FDA Approval of PREVYMIS™ (letermovir)

Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
- Source: finance.yahoo
- 1,104
- November 10, 2017
CMV FDA HSCT New Approvals
FDA Announces New Policy for Genetic Testing Regulation

In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
- Source: jdsupra
- 524
- November 10, 2017
direct-to-consumer genetic risk Policy
FDA Approves Genentech’s Alecensa Lung Cancer Treatment

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
- Source: Pharmpro
- 596
- November 9, 2017
ALK FDA New Approvals NSCLC sNDA
FDA Lifts Clinical Hold on Cellectis Phase 1 Clinical Trials with UCART123 in AML and BPDCN

Cellectis (Alternext: ALCLS - Nasdaq: CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- Source: Cellectis
- 561
- November 9, 2017
Cellectis Clinical Trials FDA immunotherapies UCART
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer

The U.S. Food and Drug Administration(FDA) has expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD.
- Source: Worldpharmanews
- 439
- November 8, 2017
BRAF V600 ECD FDA Zelboraf (vemurafenib)
FDA Widens Scope of Navigator – Information Tool for Expanded Access

FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address the needs of a patient with a rare disease. Therefore, the agency needs to take new steps to enable more patients with unmet needs to get access to promising treatments prior to full FDA approval.
- Source: blogs.fda.gov
- 571
- November 6, 2017
FDA orphan Policy treatment

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