FDA – Page 7 – 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
- 619
- 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
- 640
- 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
- 950
- April 19, 2018
biopharmaceutical FDA New Approvals rare and ultra-rare diseases
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
- 628
- 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
- 674
- April 13, 2018
AI FDA New Approvals
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
- 536
- April 11, 2018
FDA New Approvals rucaparib
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer

Application based on results from Phase 2 CheckMate -142 study
- Source: investors.bms
- 613
- April 11, 2018
Bristol-Myers Squibb FDA New Approvals Opdivo
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
- 642
- April 9, 2018
AbbVie biosimilar FDA Genentech
Adherium receives OTC clearance for AstraZeneca’s Symbicort inhaler

Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
- Source: MobiHealthNews
- 801
- April 7, 2018
COPD FDA New Approvals
EU reviews for Sanofi’s Dupixent, cemiplimab

European regulators have agreed to review Sanofi and Regeneron’s Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma.
- Source: pharmatimes
- 950
- April 4, 2018
asthma FDA New Approvals Sanofi

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