The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System
On Jul. 7, 2020, the FDA alerted clinical laboratory staff and health care providers of an increased risk…
The FDA reported false positive results with BD SARS-CoV-2 reagents for the BD Max System
On Jul. 7, 2020, the FDA alerted clinical laboratory staff and health care providers of an increased risk…
LabCorp lanuched first digital COVID-19 service that improves the doctor and patient experience
On Jul. 7, 2020, LabCorpï¾® launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
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…
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 FDA issued an emergency use authorization (EUA) for the third diagnostic test for…
The FDA approved Qwo (collagenase clostridium histolyticum-aaes), the first injectable treatment for cellulite
On Jul. 6, 2020, Endo International announced that it received FDA approval of Qwo (collagenase clostridium histolyticum-aaes) for…
ADMA Biologics opened its newest ADMA BioCenters plasma collection facility
On Jul. 6, 2020, ADMA Biologics announced the commencement of operations and initiation of collections at its newest…
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…
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…
Biotechnology | FDA | HIV | Life Science News | 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…
FDA issued Emergency Use Authorization for Philips’ acute care patient monitoring solutions for hospitals
On Jul. 2, 2020, Royal Philips announced that the FDA had issued an Emergency Use Authorization (EUA) for…
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 FDA had…
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…
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…
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 FDA for…
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…
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…
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…
The FDA announced first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
On Jun. 23, 2020, the FDA launched Project Patient Voice, an initiative of the FDAï¾’s Oncology Center of…
Takeda received FDA approval to manufacture ENTYVIO (vedolizumab) drug substance at Brooklyn Park, Minnesota facility
On Jun. 23, 2020, Takeda Pharmaceutical announced that the FDA had approved the company’s submission for its biologics…
The FDA announced participation in the COVID-19 Diagnostics Evidence Accelerator
On Jun. 18, 2020, the FDA announced participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project…
The FDA approved first therapy for rare disease that causes low phosphate blood levels, bone softening
On Jun. 18, 2020, the U.S. Food and Drug Administration (FDA) approved Ultragenyx Pharmaceutical ‘s Crysvita (burosumab-twza) injection…
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…
The FDA revoked Emergency Use Authorization for Chembio antibody test
On Jun. 16, 2020, the FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic System DPP…
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…
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…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | 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…
SIGA Technologies announced Department of Defense increased funding to develop posteExposure prophylactic indication for TPOXX
On Jun. 15, 2020, SIGA Technologies announced the U.S. Department of Defense (DoD) increased research and development funding…
FDA approved HPV vaccine Gardasil as throat cancer prevention
On Jun. 12, 2020, the FDA announced it had approved an expanded indication for Merck’s GARDASIL9 for the…
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…