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FDA Approves Additional Doses of Trulicity (dulaglutide) for the Treatment of Type 2 Diabetes
drugs.com
September 23, 2020
The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company's (NYSE: LLY) Trulicity® (dulaglutide). The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from
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FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
drugs.com
September 23, 2020
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection ...
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Heron Announces Successful FDA Meeting for Postoperative Pain Treatment
americanpharmaceuticalreview
September 23, 2020
Heron Therapeutics announced a successful Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the plans for the Company to resubmit the New Drug Application (NDA) for HTX-011 for the management of p...
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FDA Approves Qdolo
drugs.com
September 23, 2020
Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV.
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Preparation products of Yiling Pharma approved by FDA for launch in the US market
prnasia
September 21, 2020
Yiling Pharmaceutical Co., Ltd. announced on Friday that it had received the approvals of the Abbreviated New Drug Applications (ANDA) about Lisinopril Tablets and Acyclovir Capsules, from United States Food and Drug Administration ...
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Zydus Cadila gets US FDA nod for potassium chloride extended-release tablets
expresspharma
September 21, 2020
It is a mineral supplement used to treat or prevent low amounts of potassium in the blood.
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T cells take the lead in controlling SARS-CoV-2 and reducing COVID-19 disease severity
worldpharmanews
September 18, 2020
Ever since SARS-CoV-2 first appeared, researchers have been trying to understand whether sometimes the immune system does more harm than good during the acute phase of COVID-19.
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Drug Candidate GLR2007 Granted FDA Orphan Drug Designation
americanpharmaceuticalreview
September 18, 2020
Gan & Lee Pharmaceuticals announced the U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation for GLR2007, for the treatment of malignant glioma. GLR2007 is a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor that ...
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FDA Grants Dupixent Breakthrough Therapy Designation for Eosinophilic Esophagitis
americanpharmaceuticalreview
September 18, 2020
Regeneron Pharmaceuticals and Sanofi announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent® (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE).
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Sorrento gets US FDA nod for Phase 1 clinical trial of neutralising antibody in COVID-19 patients
expresspharma
September 18, 2020
Sorrento had earlier informed that COVI-GUARD (STI-1499) demonstrated 100 per cent in vitro neutralizing effect against SARS-CoV-2.