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PharmaCyte Biotech Announces Closing of $70 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules
firstwordpharma
August 24, 2021
PharmaCyte Biotech, Inc. (NASDAQ: PMCB) today announced the closing of its previously announced registered direct offering priced at-the-marked under Nasdaq rules, of 14,000,000 shares of the Company's common stock
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FDA: Stop Using Eco-Med Ultrasound Gels, Lotions
drugs
August 20, 2021
Health care providers and facilities should immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical Inc. due to a risk for bacterial contamination, according to a letter to health care providers published.
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FDA Approves TicoVac (tick-borne encephalitis vaccine) to Prevent Tick-Borne Encephalitis (TBE)
drugs
August 20, 2021
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TicoVac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older.
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VTX-801 Receives U.S. FDA Fast Track Designation for the Treatment of Wilson Disease
drugs
August 20, 2021
Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy.
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Lilly, Boehringer's Jardiance bags FDA approval for heart failure
firstwordpharma
August 19, 2021
The FDA has expanded the label for Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) to include reducing the risk of cardiovascular death plus hospitalisation for heart failure (HF) in adult patients with reduced ejection fraction (HFrEF).
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GSK's Jemperli scores FDA nod for mismatch repair-deficient solid tumours
firstwordpharma
August 18, 2021
GlaxoSmithKline said the FDA has expanded the label for Jemperli (dostarlimab-gxly) to include treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults
drugs
August 16, 2021
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.
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FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
drugs
August 16, 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor.
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Xywav Gets FDA Approval to Treat Rare Sleep Disorder
drugs
August 16, 2021
The drug Xywav has been approved for expanded use in adults with the rare sleep disorder idiopathic hypersomnia, the U.S. Food and Drug Administration said Thursday.
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Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
prnewswire
August 16, 2021
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals