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FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for COVID-19 Test americanpharmaceuticalreview
March 17, 2020
Thermo Fisher Scientific announced on March 13, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for its diagnostic test ...
Agenus Receives Fast Track Designation for Cervical Cancer Treatment americanpharmaceuticalreview
March 17, 2020
Agenus announced the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab [PD-1] in combination ...
Fast Track designation granted to chronic kidney disease treatment europeanpharmaceuticalreview
March 17, 2020
The US FDA has granted Fast Track designation to Jardiance® for the treatment of chronic kidney disease.
FDA Issues EUA to Thermo Fisher contractpharma
March 17, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s diagnostic test that can be used immediately...
Alkem Labs gets EIR from US FDA for Baddi facility expresspharma
March 16, 2020
Alkem Laboratories said the US health regulator has issued an establishment inspection report (EIR) for its manufacturing facility at Baddi in Himachal Pradesh.
FDA Provides Surgical Mask, Gown Conservation Strategies americanpharmaceuticalreview
March 16, 2020
The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits ...
FDA Grants Fast Track Designation to Jardiance for Chronic Kidney Disease americanpharmaceuticalreview
March 16, 2020
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of Jardiance® (empagliflozin) to reduce the risk of kidney disease progression ...
U.S. Food and Drug Administration approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for patients with hepatocellular carcinoma (HCC) previously treated with sorafenib worldpharmanews
March 12, 2020
Bristol Myers Squibb Company announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients ...
Spero Receives Orphan Drug Designation for Nontuberculous Mycobacterial Treatment americanpharmaceuticalreview
March 12, 2020
Spero Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for oral SPR720 for the treatment of nontuberculous mycobacterial (NTM) infection.
Almost 400 cell and gene therapies in US pipeline, finds report europeanpharmaceuticalreview
March 12, 2020
New research has found that there are 362 cell and gene therapies in clinical pipelines in the US, an increase from 2018.

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