January 16, 2018
Midatech conducts study on childhood brain cancer drug in USA
Midatech Pharma will conduct a study of an investigational new drug for the treatment of the fatal childhood brain cancer…
Pharmaceuticals, Biotechnology and Life Sciences
Tag: FDA
January 16, 2018
FDA says Teva’s Trisenox injection for certain acute promyelocytic leukemia can be used in combination with tretinon
Israel’s largest drugmaker, and world’s renown generic drug’s leading producer Teva, through it’s USA outpost Teva Ltd, said that that…
January 16, 2018
FDA broadens Boehringer Ingelheim’s afatinib indication to previously untreated, metastatic NSCLC
Boehringer Ingelheim Pharmaceuticals has gotten an approval from the FDA, for a broadened indication of its afatinib for patients with…
January 12, 2018
FDA OKs first treatment for breast cancer with a certain inherited genetic mutation
The FDA has expanded the use of AstraZeneca’s Lynparza, the treatment for certain types of breast cancer patients, making it the…
January 11, 2018
FDA warns BD about flaws in lead testing issues
The U.S. Food and Drug Administration said Thursday it has warned Becton Dickinson (BD) about several violations of federal law. BD…
December 19, 2017
Shire receives FDA clearance for myPKFiT
The U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance to Shire’s myPKFiT for ADVATE, a free web-based…
December 18, 2017
US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of AstraZeneca’s…
December 12, 2017
FDA will review Eli Lilly’s Galcanezumab for the prevention of migraine in adults
Eli Lilly said on Monday that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) to review…
November 15, 2017
FDA OK’s AstraZeneca’s breast cancer drug
US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s Faslodex(fulvestrant), expanding the indication to include use with…
November 2, 2017
GSK’s investigational BCMA antibody-drug gets FDA breakthrough therapy designation
GlaxoSmithKline said on Thursday that its investigational BCMA antibody-drug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration…