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Lilly Receives FDA Approval of TAUVID for Patients Being Evaluated for Alzheimer's Disease
americanpharmaceuticalreview
June 09, 2020
TAUVID™ has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment ...
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COVID-19 Update: FDA Shares Antibody Test Performance Data
contractpharma
June 09, 2020
Independently evaluates certain antibody tests, including antibody tests that were not the subject of an EUA or pre-EUA, and those that were under FDA review.
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FDA approves Recarbrio for treatment of bacterial pneumonias
europeanpharmaceuticalreview
June 09, 2020
Recarbrio (imipenem-cilastatin and relebactam) was approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
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US FDA grants Lupin’s Mexiletine Orphan Drug Designation
expresspharma
June 09, 2020
Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia.
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Merck’s sNDA for RECARBRIO Wins FDA Approval
contractpharma
June 08, 2020
For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by Gram-negative microorganisms.
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Zydus Cadila get US FDA approval for Atazanavir capsules
expresspharma
June 08, 2020
It is used to treat HIV infection, in combination with other antiretrovirals.
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FSD Pharma gets FDA nod to design Covid-19 trial with ultramicronised PEA
pharmaceutical-business-review
June 05, 2020
FSD Pharma has secured approval from the US Food and Drug Administration (FDA) to design a phase 2a clinical trial to evaluate the efficacy of FSD-201 ...
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FDA approves Merck’s antibiotic drug to treat hospital-acquired bacterial pneumonia
expresspharma
June 05, 2020
The US Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.
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AVEO Oncology announces FDA acceptance for filing of an NDA for Tivozanib as treatment of relapsed o
pharmaceutical-business-review
June 04, 2020
AVEO Oncology announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib ...
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FDA Provides New Tool to Aid Development, Evaluation of SARS-CoV-2 Tests
americanpharmaceuticalreview
June 04, 2020
The U.S. Food and Drug Administration (FDA) took a new step to support the agency’s evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel.