Search Results for “FDA” – Page 63 – media

FDA ‘conflicted’ on Lilly and Incyte’s refiled baricitinib

Eli Lilly and Incyte’s second attempt to get U.S. approval of rheumatoid arthritis drug baricitinib could be scuppered again by lingering FDA concerns about safety. A briefing document published ahead of the April 23 advisory committee meeting on baricitinib suggests that Lilly and Incyte’s lightning-fast amendment and refile of the dossier hasn’t added enough data to persuade the FDA to change its stance on the risk of blood clots with the JAK inhibitor.
- Source: Fiercebiotech; new approvals
- 615
- April 24, 2018
baricitinib Eli Lilly FDA rheumatoid arthritis
FDA’s 2019 budget request cites digital health; agency rolls out medical device initiative

Digital health appears to be making its way onto the national stage. On Tuesday, FDA Commissioner Scott Gottlieb gave the field a shout-out in his remarks to the US House Subcommittee on Agriculture, Rural Development concerning the Fiscal Year 2019 budget request for the FDA.
- Source: MobiHealthNews
- 634
- April 20, 2018
digital health FDA
Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)

First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease
- Source: globenewswire
- 946
- April 19, 2018
biopharmaceutical FDA New Approvals rare and ultra-rare diseases
Shire——FDA approves VONVENDI® for perioperative management of bleeding in adult patients with von Willebrand disease

Cambridge, Ma. -- Shire plc, the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD).
- Source: 4-traders;
- 586
- April 19, 2018
New Approvals rVWF VONVENDI VWD
FDA medical device plan zeros in on cybersecurity, public-private partnership

The agency released a five-point plan outlining regulatory changes to bolster medical device safety, including requiring manufacturers ensure devices can be updated and patched.
- Source: HealthcareIT News
- 616
- April 19, 2018
cybersecurity digital health FDA Policies
FDA approves first AI-powered device to detect diabetic retinopathy

The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes.
- Source: Drug Delivery Business News
- 671
- April 13, 2018
AI FDA New Approvals
FDA Prolongs Review Date for AbbVie Endometriosis Candidate

The FDA extends the review period of NDA for AbbVie (ABBV) and partner Neurocrine Biosciences' endometriosis candidate, elagolix, by three months to third-quarter 2018.
- Source: finance.yahoo
- 534
- April 12, 2018
elagolix endometriosis New Approvals
FDA restricts sales of a Bayer’s Essure birth control device

The Food and Drug Administration(FDA) moved Monday to put sales restrictions on a Bayer birth control implant that has been a target of consumer criticism.
- Source: Usatoday
- 505
- April 11, 2018
Company Insights contraceptive device
FDA Approves Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

On April 6, 2018, the Food and Drug Administration(FDA) approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
- Source: asco.org
- 532
- April 11, 2018
FDA New Approvals rucaparib
Rejection–FDA Issues CLRs for Two Celltrion and Teva Biosimilars

The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
- Source: biospace
- 639
- April 9, 2018
AbbVie biosimilar FDA Genentech

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