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FDA Announces Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2
americanpharmaceuticalreview
November 06, 2020
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the ...
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Neuraly gets FDA clearance of INDA to initiate phase 2b trial of NLY01 in Alzheimer’s Disease
pharmaceutical-business-review
November 06, 2020
Neuraly announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease.
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ACG acquires significant stake in IQGEN-X
expresspharma
November 05, 2020
ACG, integrated pharma manufacturing solutions provider announced the acquisition of a significant stake in Mumbai-based start-up IQGEN-X, a contract research organisation (CRO) delivering niche and complex drug development technologies for the pharma ...
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Boston Scientific Receives FDA Approval for the Ranger Drug-Coated Balloon
americanpharmaceuticalreview
November 05, 2020
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval of the Ranger™ Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal ...
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FDA publishes list of essential medicines and medical countermeasures
europeanpharmaceuticalreview
November 05, 2020
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
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Senhwa Announces Multiple IND application submissions to U.S. FDA for Silmitasertib as a Potential Treatment for COVID-19
prnasia
November 04, 2020
Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced that it has submitted an Investigational New Drug (IND) application with the ...
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FDA approves first-in-human trial of COVID-19 vaccine candidate
europeanpharmaceuticalreview
November 02, 2020
The safety and immunogenicity of CORVax12, a novel DNA-encodable COVID-19 vaccine, will be evaluated in 36 healthy volunteers.
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Vanda Receives FDA Approval to Proceed with VSJ-110 for Allergic Conjunctivitis
americanpharmaceuticalreview
November 02, 2020
Vanda Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 (previously known as ...
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FDA Approves Companion Diagnostic to Identify NTRK Fusions in Solid Tumors for Vitrakvi
americanpharmaceuticalreview
November 02, 2020
The U.S. Food and Drug Administration (FDA) has approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine) as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase (NTRK) genes, NTRK1 ...
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Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease
pharmaceutical-business-review
October 30, 2020
Kala Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.