T2 Biosystems announces US launch of COVID-19 diagnostic test
On Jul. 1, 2020, T2 Biosystems announced completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2…
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Successful first harvest provided roadmap for scaling secure, domestic source of farm-raised salmon
On Jun. 30, 2020, AquaBounty Technologies announced it had successfully commenced the commercial-scale harvest of conventional Atlantic salmon…
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Biotechnology | Disease | FDA
Luminex submitted Emergency Use Authorization request to FDA for COVID-19 antibody test
On Jun. 29, 2020, Luminex announced that the company had submitted an Emergency Use Authorization request to the…
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The FDA approved new therapy for Dravet Syndrome
On Jun. 25, 2020, the U.S. Food and Drug Administration (FDA) approved Fintepla (fenfluramine), a Schedule IV controlled…
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SIGA Technologies announced deliveries of oral TPOXX to HHS valued at approximately $32 million
On Jun. 25, 2020, SIGA Technologies announced the deliveries of oral TPOXX (tecovirimat) to the U.S. Department of…
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The FDA announced first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
On Jun. 23, 2020, the U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of…
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Takeda received FDA approval to manufacture ENTYVIO (vedolizumab) drug substance at Brooklyn Park, Minnesota facility
On Jun. 23, 2020, Takeda Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) had approved the…
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Biotechnology | FDA | Oncology | Rare Disease | Therapeutics
Ultragenyx and Kyowa Kirin Announce U.S. FDA Approval of Crysvita® (burosumab) for Treatment of Tumor-Induced Osteomalacia
On Jun. 18, 2020, Ultragenyx Pharmaceutical and Kyowa Kirin announced that the U.S. Food and Drug Administration (FDA)…
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Aclaris Therapeutics supported investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized COVID-19 patients
On Jun. 17, 2020, Aclaris Therapeutics announced that the FDA had allowed an investigational new drug application to…
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The FDA revoked Emergency Use Authorization for Chembio antibody test
On Jun. 16, 2020, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of…
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The FDA warned of newly discovered potential drug interaction that may reduce effectiveness of COVID-19 treatment
On Jun. 15, 2020, the U.S. Food and Drug Administration (FDA) warned health care providers about a newly…
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The FDA revoked Emergency Use Authorization for chloroquine and hydroxychloroquine
On Jun. 15, 2020, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that…
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Biotechnology | Diagnostics | Disease | FDA | Medical Device | Neurology | Therapeutics
The FDA permitted marketing of first game-based digital therapeutic to improve attention function in children with ADHD
On Jun. 15, 2020, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital…
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SIGA Technologies announced Department of Defense increased funding to develop Post Exposure prophylactic indication for TPOXX
On Jun. 15, 2020, SIGA Technologies announced that it had been awarded a multi-year contract from the United…
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Dr. Reddy’s Laboratories entered into a licensing agreement with Gilead Sciences for Remdesivir
On Jun. 13, 2020, Dr. Reddy’s Laboratories announced that it had entered into a non-exclusive Licensing Agreement with Gilead…
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Cue Health received FDA EUA for Its rapid, portable, molecular point-of-care COVID-19 test
On Jun. 12, 2020, Cue Health announced that it had received Emergency Use Authorization from the U.S. Food…
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Biotechnology | CDC | FDA | HIV | Therapeutics
The FDA approved drug to treat infants and children with HIV
On June 12, 2020, the U.S. Food and Drug Administration (FDA) approved Tivicay (dolutegravir) tablets and Tivicay PD…
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Biotechnology | FDA | HIV | Therapeutics
ViiV Healthcare announced FDA approval of the first-ever dispersible tablet formulation of dolutegravir for children living with HIV
On Jun. 12, 2020, ViiV Healthcare, a GSK company, with Pfizer and Shionogi Limited, announced the FDA had…
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Biotechnology | FDA | Oncology | Vaccine
FDA approved HPV vaccine Gardasil as throat cancer prevention
On Jun. 12, 2020, the Food and Drug Administration (FDA) announced it had approved an expanded indication for…
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Biotechnology | FDA | Medicine | Oncology | Pharmaceutical | Radiology | Therapeutics
FDA approved Bristol-Myers’ Opdivo’ (nivolumab) for treatment of patients with advanced esophageal squamous cell carcinoma
On Jun. 11, 2020, Bristol-Myers Squibb announced that Opdivo ® (nivolumab) was approved by the U.S. Food and…
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FDA | Neurology | Ophthalmogy | Rare Disease
The FDA approved new therapy for rare disease affecting optic nerve, spinal cord
On Jun. 11, 2020, the U.S. Food and Drug Administration approved Viela Bio’s Uplizna (inebilizumab-cdon) injection for intravenous…
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Moderna advanced late-stage development of vaccine (mRNA-1273) against COVID-19
On Jun. 11, 2020, Moderna announced progress on late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against…
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Biotechnology | COVID-19 | Diagnostics | FDA | Therapeutics
InBios received FDA Emergency Use Authorization for COVID-19 antibody test
On Jun. 11, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the U.S. Food…
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The FDA authorized first next generation sequence test for diagnosing COVID-19
On Jun. 10, 2020, the the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA)…
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Illumina received first FDA Emergency Use Authorization for sequencing-based COVID-19 diagnostic test
On Jun. 9, 2020, Illumina announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization…
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Quidel’s received amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay
On Jun. 9, 2020, Quidel announced that is had received an amended Emergency Use Authorization (EUA) from the…
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Immunic announced FDA allowance of its phase 2, CALVID-1 clinical trial of IMU-838 in COVID-19
On Jun. 9, 2020, Immunic announced receipt of regulatory allowance from the FDA to initiate its phase 2,…
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OraSure’s Oragene-Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test
On Jun. 8, 2020, OraSure Technologies announced that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for…
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Sorrento announced COVIDTRAP(STI-4398) demonstrated in preclinical studies its ability to completely inhibit SARS-CoV-2 viral infection In vitro
On Jun. 5, 2020, Sorrento announced it had completed a preclinical batch of the STI-4398 (COVIDTRAP) protein and…
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FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
On Jun. 4, 2020, Merck announced that the U.S. Food and Drug Administration (FDA) had approved a supplemental…
