Search Results for “FDA” – Page 77 – media

FDA grants fast-track designation for Shire’s lung drug

The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants.
- Source: Pharmatimes
- 579
- September 14, 2017
chronic Clinical lung New Approvals
FDA sends damning warning letter to Pfizer after misfiring EpiPens linked to deaths

The US Food and Drug Administration(FDA) has sent a damning warning letter to drug giant Pfizer Inc (NYSE:PFE) after it received “hundreds of complaints” that the anti-allergy EpiPen device misfired “during life-threatening emergencies”.
- Source: Proactiveinvestors
- 691
- September 11, 2017
anti-allergy FDA
Sanofi wins tentative FDA nod for Admelog insulin lispro injection

Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
- Source: yahoo
- 736
- September 7, 2017
Company Insight diabetes FDA insulin New Approvals
FDA holds trials of Cellectis’ cell therapy after patient death

US regulators have placed on hold studies of French drugmaker Cellectis’ CAR-T therapy following a patient fatality.
- Source: news.open-medical
- 574
- September 6, 2017
BPDCN CAR–T Clinical Trials Company Insight CRS
FDA approves Adherium’s new inhaler monitoring device

The US Food and Drug Administration (FDA) has cleared Adherium for its new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
- Source: medicaldevices-business-review
- 572
- September 5, 2017
Company Insight FDA inhaler respiratory
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.
- Source: biospace
- 559
- September 5, 2017
cancer FDA follicular lymphoma New Approvals sBLA
FDA approves Teva’s Austedo for tardive dyskinesia

Teva’s Austedo is now the first and only therapy approved in the US to treat both tardive dyskinesia and chorea associated with Huntington’s disease.
- Source: news.open-medical
- 656
- September 1, 2017
chorea FDA New Approvals tardive dyskinesia Teva
FDA Approves New Antibiotics to Treat Kidney Infections by “Superbugs”

Adult peoples with complicated urinary tract infections (cUTI) like pyelonephritis– a type of kidney infection caused by specific bacteria- suffer from many inconvenient problems like painful urination. It may lead to serious life threatening conditions including permanent kidney damage.
- Source: medgenera
- 733
- August 31, 2017
cUTI kidney New Approvals pyelonephritis
Titan wins FDA nod to study Parkinson’s implant

Titan Pharmaceuticals’ stated today that their ropinirole implant, designed to treat the symptoms of Parkinson’s disease, was cleared by the FDA today as a new drug application.
- Source: drugdeliverybusiness
- 650
- August 25, 2017
Clinical Trials formulation implant New Approvals Parkinson
Biotronik’s tiny, MRI-safe CRT pacemaker secures FDA approval

Biotronik has secured approval from the US Food and Drug Admini(FDA) for its Edora HF-T QP, a MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P).
- Source: medicaldevices
- 535
- August 23, 2017
cardiac Company Insight New Approvals QP

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