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Amivas Announces FDA Approval of Artesunate for Injection for Severe Malaria
americanpharmaceuticalreview
June 02, 2020
Amivas announced Artesunate for Injection 110 mg, powder and solvent for solution has received marketing approval by the US Food and Drug Administration (FDA).
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Relmada Announces Outcome of FDA Meeting for Major Depressive Disorder Treatment
americanpharmaceuticalreview
June 02, 2020
Relmada Therapeutics announced the completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 (dextromethadone) for the adjunctive treatment of major depressive disorder (MDD) patients.
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FDA approves CYRAMZA® (ramucirumab) for EGFR-mutated non-small cell lung cancer
europeanpharmaceuticalreview
June 02, 2020
CYRAMZA in combination with erlotinib was approved as a first-line treatment for metastatic EGFR-mutated non-small cell lung cancer.
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AstraZeneca’s heart disease drug Brilinta gets FDA approval
pharmaceutical-technology
June 02, 2020
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Brilinta (ticagrelor) to decrease the risk of a first heart attack or stroke in high-risk patients suffering from coronary artery disease (CAD).
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FDA Authorizes Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit
americanpharmaceuticalreview
June 01, 2020
Quest Diagnostics has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Quest Diagnostics Self-Collection Kit for COVID-19.
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NeuroBo Announces Continuation of Partial Clinical Hold of Gemcabene
americanpharmaceuticalreview
June 01, 2020
NeuroBo Pharmaceuticals announced it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for Gemcabene.
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FDA Lists Beckman Coulter RNA Extraction Kit for Use in EUA-Authorized COVID-19 Test
americanpharmaceuticalreview
June 01, 2020
Beckman Coulter Life Sciences announced RNAdvance Viral XP has been added to the list of acceptable extraction methods for use in the Centers for Disease Control's EUA-authorized COVID-19 test referenced in the FDA's FAQ on testing for SARS-CoV-2.
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US FDA approves first drug to image Tau Pathology in Alzheimer’s Disease related cases
expresspharma
June 01, 2020
Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.
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FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastati
pharmaceutical-business-review
May 29, 2020
Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) ...
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PhaseBio gets FDA nod to begin Covid-19 trial with VIP receptor agonist PB1046
pharmaceutical-business-review
May 29, 2020
PhaseBio Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to begin a VANGARD pivotal clinical to assess PB1046 as a treatment for hospitalised Covid-19 patients.