Search Results for “FDA” – Page 65 – media

Smiths Medical touts FDA nod, US launch of DeltaVan catheter

Smiths Medical today touted the FDA clearance and US launch of Delta Med’s DeltaVan closed system catheter.
- Source: MassDevice
- 564
- March 26, 2018
catheter FDA medical device products New Approvals
Eli Lilly gets a date with FDA experts for once-rejected rheumatoid arthritis drug baricitinib

Eli Lilly’s one-time blockbuster hopeful baricitinib $LLY is back and on track and ready to run a gamut of outside experts at the FDA.
- Source: Endpts
- 623
- March 23, 2018
baricitinib Company Insight FDA
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
- Source: finance.yahoo
- 582
- March 22, 2018
ADCETRIS cancer FDA Hodgkin lymphoma New Approvals
FDA Approves Hizentra® (Immune Globulin Subcutaneous 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

First and only subcutaneous immunoglobulin (SCIg) approved for the treatment of CIDP based on the largest controlled clinical study in CIDP
- Source: finance.yahoo
- 683
- March 20, 2018
CIDP FDA Hizentra® New Approvals
Abeona Therapeutics Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease

Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the FDA has granted Rare Pediatric Disease Designation for the ABO-202 program (AAV-CLN1), an AAV-based gene therapy for the treatment of CLN1 disease (infantile and late infantile onset Batten disease).
- Source: Tmcnet
- 429
- March 19, 2018
CLN1 disease lysosomal storage New Approvals
Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer

Erdafitinib, an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, shows promise as the first targeted agent for patients with metastatic urothelial cancer, one of the most common cancers
- Source: janssen
- 614
- March 19, 2018
erdafitinib FDA Janssen Johnson & Johnson
FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch

Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
- Source: polyganics
- 650
- March 15, 2018
bioresorbable medical devices FDA New Approvals Polyganics
Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge

The FDA has slapped a clinical hold on a combo therapy using Advaxis’$ADXS axalimogene filolisbac along with AstraZeneca’s approved PD-L1 Imfinzi following the death of a patient in their Phase I/II trial.
- Source: endpts
- 621
- March 15, 2018
AstraZeneca cervical cancer Company Insight FDA
Busy Sanofi takes a pass on one of Alnylam’s rare disease drugs, FDA offers ‘breakthrough’ status for PhIII

A couple of months after Sanofi $SNY and Alnylam $ALNY retooled their RNAi collaboration so that the French pharma giant could concentrate on their hemophilia therapy while giving up rights to the biotech’s patisiran, the two partners are also going their separate ways on a late-stage drug for rare cases of primary hyperoxaluria type 1.
- Source: Endpts
- 561
- March 14, 2018
hemophilia lumasiran New Approvals RNAi
CFDA Continues to Expand Oversea Inspection

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
- Source: drugdu
- 651
- March 14, 2018
CFDA medical device products Policies

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