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FDA Approves Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patien biospace
March 19, 2018
CSL Behring today announced that FDA approved Hizentra®as the first and only SCIg for the treatment of CIDP as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
FDA Gives Go-Ahead for Tetra's Phase II Trial biospace
March 19, 2018
Tetra Discovery Partners announced that the U.S. Food and Drug Administration (FDA) had given its Investigational New Drug application (IND)
Food And Drug Administration Grants Clearance For ReddyPort's NIV Access Elbow biospace
March 16, 2018
ReddyPort Inc. announced today that it received United States regulatory clearance from FDA for its ReddyPort NIV Access Elbow The ReddyPort Elbow is the first multiple-use access elbow that attaches to noninvasive ventilation masks.
Tobacco-Free Kids: FDA Plan to Reduce Nicotine Levels in Cigarettes Would Save Millions of Lives - A biospace
March 16, 2018
The U.S. Food and Drug Administration formally asks the public to solicit public opinion on its proposal to minimize or to no addiction to nicotine in tobacco
FDA Slaps Clinical Hold on Solid Bioscience DMD Gene Therapy Program biospace
March 16, 2018
FDA decision to slap a clinical hold on Solid Biosciences’s experimental gene therapy treatment for Duchenne muscular dystrophy sent share prices plunging late Wednesday and into early trading this morning.
FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumt biospace
March 15, 2018
Merz North America announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA)
Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar biospace
March 15, 2018
CeraPedics Corporation announced today that the company has been approved by the U.S. Food and Drug Administration (FDA)
Zydus Cadila gets US FDA nod for Tizanidine tablets expressbpd
March 14, 2018
Cadila Healthcare said its group firm Zydus Cadila has received final approval from the US health regulator for its generic version of Tizanidine tablets used for treatment of muscle spasms.
FDA Grants Merck's Keytruda Priority Review for Cervical Cancer biospace
March 14, 2018
The U.S. Food and Drug Administration (FDA) accepted Merck & Company’s supplemental Biologics License Application and granted Priority Review for Keytruda (pembrolizumab) in advanced cervical cancer.
Proteostasis Therapeutics Snags Breakthrough Designation biospace
March 14, 2018
Investors in Cambridge, Mass.-based Proteostasis Therapeutics are smiling this morning after FDA granted the company’s investigational cystic fibrosis add-on therapy the Breakthrough Therapy Designation.

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