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Strides Shasun arm gets US FDA nod for allergy relief drug expressbpd
April 13, 2018
The drug will be manufactured at its oral dosage facility at Bengaluru and will be marketed by Strides Pharma in the US
SpinalCyte Applies with FDA to Expand Human Clinical Trial of CybroCell™ Dermal Fibroblasts as Investigational New Drug (IND) biospace
April 13, 2018
SpinalCyte, LLC has filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to expand its study of CybroCell Human Dermal Fibroblasts to treat degenerative disc disease.
TransMedics, Inc. Receives FDA Pre-Market Approval (PMA) for its OCS™ Lung System for Near-Physiologic Preservation and Assessment of Lungs for Transplantation biospace
April 13, 2018
TransMedics, Inc announced today that the U.S. Food and Drug Administration (FDA) approved its Pre-Market Approval Application for the Organ Care System Lung platform for the standard double lung transplant indication
FDA Permits Marketing of IDx-DR for Automated Detection of Diabetic Retinopathy in Primary Care biospace
April 13, 2018
IDx Inc., a privately-held AI diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company's De Novo request to market IDx-DR
Translate Bio Announces FDA Clearance to Proceed with Phase 1/2 Clinical Trial in Patients with Cystic Fibrosis (CF) biospace
April 13, 2018
Translate Bio today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to begin a first-in-human clinical trial of MRT5005 in patients with cystic fibrosis
FDA Launches Criminal Investigation into Rational Vaccines Over Unauthorized Herpes Research biospace
April 13, 2018
One month after the three patients who had an adverse reaction after the injection of an unauthorized herpes vaccine filed a suit against a rational vaccine, the US Food and Drug Administration (FDA) launched a criminal investigation.
LENSAR® Laser System Receives FDA Clearance to Perform Corneal Pockets and Flaps for Corneal Inlay Procedures biospace
April 12, 2018
LENSAR Laser System with Streamline™ IV Expands the Powerful Refractive Cataract Femtosecond Platform to Support the Surgical Treatment of Presbyopia
FDA Pushes Back PDUFA Date for AbbVie’s Endometriosis Drug biospace
April 12, 2018
The U.S. Food and Drug Administration wants more time to review AbbVie’s elagolix, a treatment for endometriosis-associated pain.
FDA clears first contact lens with light-adaptive technology biospace
April 11, 2018
The U.S. Food and Drug Administration today cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light.
Reviva Pharmaceuticals Receives FDA Orphan Designation for RP5063 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) firstwordpharma
April 11, 2018
Reviva Pharmaceuticals, Inc. today announced that the FDA has granted Orphan Drug Designation for its clinical stage drug candidate, RP5063, for the treatment of idiopathic pulmonary fibrosis (IPF).

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