FDA – Page 9 – media

FDA clears new Dexcom CGM that requires no patient calibration earlier than expected

Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
- Source: MedCityNews
- 718
- March 29, 2018
diabetes FDA insulin New Approvals
Bayer announces completion of rolling submission of New Drug Application in the U.S. for larotrectinib for the treatment of TRK fusion cancer

Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
- Source: investor.bayer.de
- 596
- March 28, 2018
FDA larotrectinib New Approvals NTRK
Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA Priority Review designation; provides clinicians with pediatric-specific safety and clinical data Novartis continues commitment to people living with CML, including pediatric patients with this cancer
- Source: novartis
- 649
- March 26, 2018
chronic myeloid leukemia Clinical Trials FDA Tasigna®
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
- 580
- 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
- 638
- 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
- 598
- 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
- 694
- March 20, 2018
CIDP FDA Hizentra® 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
- 626
- 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
- 660
- 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
- 632
- March 15, 2018
AstraZeneca cervical cancer Company Insight FDA

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