FDA – Page 17 – media

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
- 576
- 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
- 1,116
- November 10, 2017
CMV FDA HSCT New Approvals
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
- 612
- 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
- 579
- 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
- 450
- 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
- 582
- November 6, 2017
FDA orphan Policy treatment
Joining ICH–Opportunity or Challenge?

Ddu has gradually made its way through Europe by attending the CPhI Worldwide 2017 in Frankfurt and Medica 2017 in Düsseldorf, Germany. During conversations with manufacturers, ICH was frequently mentioned. Since China was admitted as one of the regulatory members of ICH in June of last year, it was now placed at the forefront of the discussions.
- Source: drugdu
- 739
- November 2, 2017
Ddu College EC FDA ICH MHLW PMDA
FDA approves new treatment for adults with mantle cell lymphoma

The U.S. Food and Drug(FDA) Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
- Source: Prnewswire
- 792
- November 1, 2017
Calquence FDA mantle cell lymphoma New Approvals
FDA Calls BioMarin’s Hemophilia A Drug a Breakthrough

BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) granted its valoctocogene roxaparvovec for Hemophilia A Breakthrough Therapy Designation.
- Source: biospace
- 815
- October 31, 2017
Clinical Trial FDA hemophilia A
US FDA finalises new guidelines for medical device development

The US Food and Drug Administration (FDA) has announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.
- Source: medicaldevice-network
- 472
- October 30, 2017
FDA medical device

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