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TXT Comments Extended on Hatch-Waxman Act Meeting [106 Words] [ Price : $8.95]
Federal Register notice: FDA extends the comment period for the public meeting on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.”
09/19/2017
 
 
TXT Latest FDA Warning Letters [435 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Firson Co., Nova Homeopathic Therapeutics, Preservation Solutions and Wuxi Medical Instrument Factory.
09/19/2017
 
 
TXT FDA Denies BI Petition to Block GSK Trelegy Ellipta [2742 Words] [ Price : $8.95]
FDA approves GlaxoSmithKline’s Trelegy Ellipta COPD product and denies a Boehringer Ingelheim petition seeking to impose conditions on approval of such a product.
09/19/2017
 
 
TXT FDA Panel Mixed on Pfizer Expanded Use for Sutent [178 Words] [ Price : $8.95]
FDA’s Oncologic Drug Advisory Committee gives a mixed voted on the benefit-risk profile for Pfizer’s Sutent (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after surgical removal of the cancer-containing kidney.
09/19/2017
 
 
TXT FDA Concerns with PD-1/PD-L1 Inhibitors Spread to Roche Studies [283 Words] [ Price : $8.95]
Continuing FDA safety concerns involving PD-1/PD-L1 inhibitors spread to two Roche clinical trials, placing them on partial clinical hold.
09/18/2017
 
 
TXT FDA Approves Symbiomix Antibiotic for Vaginosis [116 Words] [ Price : $8.95]
FDA approves a Symbiomix Therapeutics NDA for Solosec (secnidazole) 2g oral granules for treating bacterial vaginosis in adult women.
09/18/2017
 
 
TXT Medtronic PMA Approved for Intellis Pain Device [132 Words] [ Price : $8.95]
FDA approves a Medtronic PMA for its Intellis platform for managing certain types of chronic intractable pain.
09/18/2017
 
 
TXT FDA Amends Animal Drug Regs to Reflect Approvals [76 Words] [ Price : $8.95]
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for a NADA and ANADAs approved during March and April.
09/18/2017
 
 
TXT Rep. Paulsen Calls for FDA Reforms [268 Words] [ Price : $8.95]
Writing in a The Hill opinion piece, Rep. Erik Paulsen (R-MN) says that reforming FDA is long overdue.
09/18/2017
 
 
TXT Ipsen sNDA for Somatuline Depot Approved [73 Words] [ Price : $8.95]
FDA approves an Ipsen Biopharmaceuticals supplemental NDA for Somatuline Depot (lanreotide) Injection 120 mg for treating carcinoid syndrome.
09/18/2017
 
 
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