FDA approved first extended-release, injectable drug regimen for adults living with HIV
On Jan. 21, 2021, the FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for…
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Janssen announced FDA approval of CABENUVA, the first long-acting HIV treatment regimen
On Jan. 21, 2021, Janssen Pharmaceutical announced the FDA had approved CABENUVA (consisting of Janssenﾒs rilpivirine and ViiV…
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Mesa Biotech received 510(k) clearance and CLIA waiver for Its Accula Strep A Molecular Point of Care Test
On Jan. 19, 2021, Mesa Biotech announced it had received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA)…
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PerkinElmer SARS-CoV-2 RT-PCR assay received FDA EUA for asymptomatic testing
On Jan. 14, 2021, PerkinElmer announced that its PerkinElmerﾮ Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization…
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Innovation Pharma’s Brilacidin for the treatment of COVID-19 received FDA Fast Track Designation
On Jan. 14, 2021, Innovation Pharmaceuticals announced that the FDA had designated as a Fast Track development program…
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FDA accepted for Priority Review the BLA for V114, Merckﾒs investigational 15-valent pneumococcal conjugate vaccine
On Jan. 12, 2021, Merck announced the FDA accepted for priority review a Biologics License Application (BLA) for…
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Abbott announced fulfillment of Federal government purchase of 150 million BinaxNOWﾙ COVID-19 Rapid Tests
On Jan. 12, 2021, Abbott announced it had received FDA 510(k) clearance for the first rapid handheld traumatic…
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Abbott received CE Mark for its COVID-19 IgG quantitative antibody blood test
On Jan. 11, 2021, Abbott announced it had received FDA 510(k) clearance for the first rapid handheld traumatic…
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Biotechnology | FDA | Oncology
FDA conditionally approved first oral tablet to treat lymphoma in dogs
On Jan. 11, 2021, the U.S. Food and Drug Administration (FDA) conditionally announced it had approved Anivive Lifesciences’…
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Biotechnology | CRISPR | FDA | Therapeutics
FDA cleared initiation of the Editas Medicine’s EDIT-301 clinical trial using CRISPR/Cas12a gene editing
On Jan. 11, 2021, Editas Medicine announced the U.S. Food and Drug Administration (FDA) had cleared the initiation…
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FDA issued alert regarding SARS-CoV-2 viral mutation to health care providers and clinical laboratory staff
On Jan. 8, 2021, the FDA alerted clinical laboratory staff and health care providers that it was monitoring…
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FDA announced statement on authorized dosing schedules for COVID-19 vaccines
On Jan. 4, 2021, the FDA announced that the two different mRNA vaccines were shown remarkable effectiveness of…
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Biotechnology | COVID-19 | FDA | NIH | Therapeutics
Medigen Vaccines obtained TFDA phase 2 IND approval for COVID19 vaccine
On Dec. 30, 2020, Medigen Vaccine Biologics announced that it had obtained TFDA Phase 2 IND approval of…
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Biotechnology | Disease | FDA | Therapeutics
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the U.S. Food and Drug Administration approved the first generic of glucagon for injection…
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Merck announced agreement with US Government for doses of Investigational biological therapy for COVID-19 patients
On Dec. 23, 2020, Merck announced an agreement with the U.S. Government to support the development, manufacture and…
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Biotechnology | COVID-19 | FDA
Quidel received EUA for moderately complex Solana SARS molecular test for COVID-19 diagnosis
On Dec. 23, 2020, Quidel announced that it had received Emergency Use Authorization (EUA) from the FDA to…
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Altimmune provided an update on investigational New Drug Application for phase 1 AdCOVIDﾙ clinical trial
On Dec. 23, 2020, Altimmune announced that the FDA had issued a clinical hold on the Companyﾒs Investigational…
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Biotechnology | COVID-19 | FDA | Therapeutics
Sorrento announced it had submitted an EUA application to the FDA for COVI-STIX rapid test for detection of SARS-CoV-2 antigen
On Dec. 22, 2020, Sorrento Therapeutics announced that an Emergency Use Authorization (EUA) Application had been submitted to…
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FDA granted IND approval for phase 2 clinical trial of Innovation Pharmasﾒ Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharma announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
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FDA granted IND approval for phase 2 clinical trial of Innovation Pharma’s Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharmaceuticals announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
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OraSure updated Its Emergency Use Authorization application for lab-based oral SARS-CoV-2 antibody test
On Dec. 21, 2020, OraSure Technologies disclosed that the FDA had requested additional information as part of its…
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FDA issued Emergency Use Authorization for second COVID-19 vaccine
On Dec. 18, 2020, the FDA issued an emergency use authorization (EUA) for the second vaccine for the…
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Moderna announced FDA authorization of Moderna COVID-19 vaccine in U.S.
On Dec. 18, 2020, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
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FDA approved prosthetic implant for above-the-knee amputations
On Dec. 18, 2020, the FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System,…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved first adjuvant therapy for most common type of lung cancer
On Dec. 18, 2020, the the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) as the…
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FDA approved first oral hormone therapy for teating advanced prostate cancer
On Dec. 18, 2020, tthe U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult…
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ACON Laboratories received Emergency Use Authorization for its SARS-COV-2 IgG/IgM rapid test
On Dec. 17, 2020, ACON Laboratories announced that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency…
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Biotechnology | COVID-19 | FDA | Vaccine
Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.
On Dec. 17, 2020, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
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Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test
On Dec. 16, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for virtually guided…
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Meridian received NIH award for supporting rapid development of Revogeneﾮ molecular test for SARS-CoV-2
On Dec. 16, 2020, Meridian Bioscience announced that it had been awarded funding in the amount of approximately…
