Luminex received FDA Emergency Use Authorization for COVID-19 antibody test
On Jul. 20, 2020, Luminex announced the Food and Drug Administration (FDA) had issued an Emergency Use Authorization…
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The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing
On Jul. 18, 2020, the U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to…
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Heron Therapeutics announced initiation of phase 2 clinical study of CINVANTI for treatment of COVID-19
On Jul. 16, 2020, Heron Therapeutics announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study…
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Biotechnology | Clinical Research | Diagnostics | FDA | Medical Device | Non-Profit Research | Oncology | Rare Disease | Stem Cell | Therapeutics | U.S. Congress
Tufts Center for the Study of Drug Development reported faster new drug approval times were more than offset by longer clinical Times in US
On Jul. 16, 2020, the Tufts Center for the Study of Drug Development reported that although regulatory approval…
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Dynavax announced first participants dosed in phase 1 clinical evaluating Medicago’s COVID-19 vaccine candidate
On Jul. 14, 2020, Dynavax Technologies announced that the first participants have been dosed in the Phase 1…
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Pfizer and BioNTech granted FDA Fast Track Designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2
On Jul. 13, 2020, Pfizer and BioNTech announced that two of the companiesﾒ four investigational vaccine candidates from…
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Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulio (adalimumab-fkjp)
On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the the U.S. Food and Drug Administration…
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Corvus Pharmaceuticals initiated clinical trial of novel immunotherapy for patients with COVID-19
On Jul. 7, 2020, Corvus Pharmaceuticals announced that it has initiated a Phase 1 study to investigate a…
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LabCorp launched first digital COVID-19 service that improves the doctor and patient experience
On Jul. 7, 2020, LabCorp launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
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Biotechnology | COVID-19 | FDA | Infectious Disease | Influenza | Vaccine
The FDA issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19
On Jul. 6, 2020, the U.S. Food and Drug Administration (FDA) announced it had issued an emergency use…
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The FDA approved Qwo (collagenase clostridium histolyticum-aaes), the first injectable treatment for cellulite
On Jul. 6, 2020, Endo International announced that it received U.S. Food and Drug Administration (FDA) approval of…
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Emergent BioSolutions signed five-year agreement for large-scale drug substance manufacturing for Johnson & Johnson’s COVID-19 vaccine candidate
On Jul. 6, 2020, Emergent BioSolutions announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, a Johnson &…
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BD launched portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, expanding access to COVID-19 testing
On Jul. 6, 2020, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had granted Emergency…
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The FDA authorized additional COVID-19 combination diagnostic test ahead of flu season
On Jul. 2, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…
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Biotechnology | FDA | HIV | Therapeutics
The FDA approved new HIV treatment for patients with limited treatment options
On Jul. 2, 2020, the U.S. Food and Drug Administration (FDA) approved Rukobia (fostemsavir), a new type of…
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FDA issued Emergency Use Authorization for Philips’ acute care patient monitoring solutions for hospitals
On Jul. 2, 2020, Royal Philips announced that the U.S. Food and Drug Administration (FDA) had issued an…
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Biotechnology | FDA | HIV | Therapeutics
ViiV Healthcare announced FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults
On Jul. 2, 2020, ViiV Healthcare, a GSK company, with Pfizer and Shionogi Limited, announced the US Food…
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MediciNova announced IND for MN-166 (ibudilast) for prevention of ARD Syndrome in patients with COVID-19
On Jul. 1, 2020, MediciNova announced that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention…
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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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InBios received FDA Emergency Use Authorization for second COVID-19 antibody test
On Jul. 1, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the U.S. Food…
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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 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…
