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US FDA approves KEYTRUDA from Merck for adults with relapsed or refractory cHL
expresspharma
October 16, 2020
KEYTRUDA is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.
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US FDA authorises phase 1 trial of ImmunityBio’s COVID-19 vaccine candidate hAd5
expresspharma
October 16, 2020
Ongoing development proceeding for oral, inhalational and intranasal administration of hAd5.
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Gannex Received U.S. IND Approval for Its NASH Drug Candidate ASC42,an FXR Agonist
prnasia
October 16, 2020
Gannex Pharma Co. announces today that it received investigational new drug application (IND) approval from FDA for its drug candidate ASC42, to conduct clinical trials for non-alcoholic steatohepatitis (NASH) indication.
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Confidence in reliability of data regarding COVID-19 therapies remains moderately high: Poll
pharmaceutical-technology
October 16, 2020
The need for a therapy to combat the contagious coronavirus disease (COVID-19) has led pharmaceutical companies to fast-track development plans, raising concerns over safety data.
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Apoptosis-Targeting Drug Candidates Granted Two More Orphan Drug Designations
americanpharmaceuticalreview
October 16, 2020
Ascentage Pharma announced the US Food and Drug Administration (FDA) has granted two Orphan Drug Designations (ODDs) to two of the company's apoptosis-targeting assets: the MDM2-p53 inhibitor, APG-115 ...
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FDA Advisory Committee Votes in Support of ALKS 3831 for Schizophrenia, Bipolar I
americanpharmaceuticalreview
October 16, 2020
Alkermes announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA).
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22 Benefits Of C B D Oil: Based On Academic Research
Health Canal
October 15, 2020
The FDA recently recommended[1] the approval of Epidiolex, this recommendation by the FDA marked an official turn in the long-standing fight to legalize cannabis-derived medicines and products.
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BryoLogyx Completes World’s First GMP Synthesis of Bryostatin-1
contractpharma
October 15, 2020
BryoLogyx has completed the synthesis of bryostatin-1 molecule, pursuant to FDA’s Good Manufacturing Practice (GMP) regulations.
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FDA Awards Grants for Rare Diseases Clinical Trials
americanpharmaceuticalreview
October 15, 2020
The U.S. Food and Drug Administration (FDA) has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years.
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Avenue Therapeutics receives complete response letter from the FDA for IV Tramadol
expresspharma
October 14, 2020
The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population.