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Cipla receives final approval for generic version of Proventil HFA Inhalation Aerosol expresspharma
April 09, 2020
Cipla announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation.
New COVID-19 At-Home Test with Social Distancing Ready for Validation Study americanpharmaceuticalreview
April 09, 2020
Care Access Research is leading a validation trial in conjunction with the FDA for a new at-home COVID-19 test developed by a private genomics lab that manufactures DNA screening kits.
Co-Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Test americanpharmaceuticalreview
April 09, 2020
Co-Diagnostics announced its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA).
FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19 americanpharmaceuticalreview
April 09, 2020
The U.S. Food and Drug Administration (FDA) continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19.
FDA authorises Emory University to trial antiviral for Covid-19 pharmaceutical-technology
April 09, 2020
Emory University subsidiary DRIVE has received the US Food and Drug Administration (FDA) approval for its investigational new drug application of antiviral compound EIDD-2801 to treat Covid-19.
US regulator postpones decision on Roche’s SMA drug risdiplam pharmaceutical-technology
April 09, 2020
The US Food and Drug Administration (FDA) has postponed the decision on Roche’s new drug application (NDA) of risdiplam to treat spinal muscular atrophy (SMA).
BD, BioGX Announce FDA Emergency Use Authorization for COVID-19 Diagnostic Test americanpharmaceuticalreview
April 08, 2020
BD announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen ...
Trxade Group Files FDA Emergency Use Authorization for Rapid COVID-19 Testing Kit americanpharmaceuticalreview
April 08, 2020
Trxade Group has filed for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in collaboration with its partnered manufacturer of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit.
Leica Biosystems Receives FDA Enforcement Discretion of Remote Diagnosis System americanpharmaceuticalreview
April 08, 2020
Leica Biosystems has received notification from the U.S. Food & Drug Administration (FDA) that its Aperio ImageScope DX Viewer with images acquired on the Aperio AT2 DX Scanner can be used for remote diagnosis under emergency use.
FDA grants Orphan Drug Designation to phenylketonuria treatment europeanpharmaceuticalreview
April 08, 2020
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.

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