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…
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FDA cleared IND for iNKT Cells to treat COVID-19 patients
On Jun. 2, 2020, Agenus announced the U.S. Food and Drug Administration’s (FDA) clearance of AgenTus’ IND application…
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FDA issued Emergency Use Authorization for Impella RP as therapy for COVID-19 patients with right heart failure
On Jun. 1, 2020, the Food and Drug Administration (FDA) announced it had issued an emergency use authorization…
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Altimmune launched clinical trial of T-COVIDTM, an investigational intranasal immune modulator for treatment of patients with early COVID-19
On Jun. 1, 2020, Altimmune announced the U.S. Food and Drug Administration (FDA) had authorized the Company to…
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FDA authorized OPKO Health clinical trial evaluating RAYALDEE in COVID-19 patients
On Jun. 1, 2020, OPKO Health announced the U.S. Food and Drug Administration (FDA) had authorized OPKO to…
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The FDA streamlined development of tests with at-home sample collection
On May 29, 2020, the U.S. Food and Drug Administration (FDA) took steps to further support the development…
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The FDA approved first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
On May 28, 2020, the FDA approved Avid Radiopharmaceuticals’ Tauvid (flortaucipir F18) for intravenous injection, the first drug…
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FDA authorized Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for emergency use
On May 28, 2020, Quest Diagnostics announced it had received emergency use authorization (EUA) from the U.S. Food…
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The FDA approved only drug in U.S. to treat severe malaria
On May 26, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Amivas’ artesunate for…
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Philips launched next generation wearable biosensor for early patient deterioration detection for COVID-19
On May 26, 2020, Royal Philips announced it had received 510(k) clearance from the FDA for its wearable…
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The FDA approved only drug in the U.S. to treat severe malaria
On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved artesunate for injection to treat severe…
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Meridian Bioscience supply reagents for manufacturing of tens of millions of COVID-19 antibody tests per month
On May 26, 2020, Meridian Bioscience announced that its SARS-CoV-2 antigens and related reagents are part of assays…
