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Other Novel Drug Approvals: Advances in Patient Care Across a Broad Range of Diseases FDA
February 09, 2018
Novel drugs are often innovative products that serve previously unmet medical needs.
2017: A Year of Innovation and Advances FDA
February 09, 2018
CDER’s drug therapy approvals of 2017 will help a wide range of patients suffering from many different diseases while many new treatment options for patients in need.
FDA warns API maker Daito Kasei Kogyo, bans some products fiercepharma
February 05, 2018
An API maker in Osaka, Japan, whose slogan is "Happiness, Awe and Surprise" has joined a growing list of Japanese drugmakers to be criticized by the FDA in warning letters.
FDA halts Bellicum trial over brain disease in participants, shares crash 48% pharmafile
February 02, 2018
Texas-based clinical-stage company Bellicum Pharmaceuticals has taken a massive stock hit after the FDA put a hold on its trials of its T-cell therapy BPX-501 due to three cases of encephalopathy in participants that are thought to be treatment-related.
Booming Celltrion Falls After FDA Warning Letter biospace
February 02, 2018
Shares of South Korea-based Celltrion are down more than 5 percent after the company announced it received a warning letter from FDA after the regulatory agency inspected a company drug manufacturing facility.
3 FDA Decisions to Look Out for in February biospace
February 02, 2018
The year is getting off to a good start for mergers and acquisitions, with Sanofi buying Bioverativ for $11.6 billion and Ablynx for $4.8 billion, Celgene acquiring Juno Therapeutics for $9 billion, and Seattle Genetics buying Cascadian Therapeutics for $
FDA Allows a Phase II Clinical Trial in Stroke for NuvOx Pharma’s DDFPe biospace
February 01, 2018
NuvOx Pharma, announces that the FDA has allowed a Phase II clinical trial in 60 stroke patients to proceed to test NuvOx’s investigational drug product, dodecafluoropentane emulsion (DDFPe).
3 Cases of Brain Damage Force the FDA to Slap a Hold on Bellicum's Lead Drug biospace
February 01, 2018
Shares of Houston-based Bellicum Pharmaceuticals plunged more than 48 percent in aftermarket trading after the company announced FDA slapped a clinical hold on its lead cell therapy product after three cases of encephalopathy were reported.
Zika vaccine candidate granted FDA fast track designation europeanpharmaceuticalreview
January 31, 2018
The FDA has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate…
FDA Grants Orphan Drug Designation to Dauntless Pharma's DP1038 for the Treatment of Acromegaly biospace
January 31, 2018
Dauntless Pharmaceuticals announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DP1038

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