Pfizer and BioNTech announced agreement with US government for up to 600 million doses of mRNA-based vaccine candidate against SARS-CoV-2
On Jul. 22, 2020, Pfizer and BioNTech announced execution of an agreement with the U.S. Department of Health…
PerkinElmer released new dried blood spot based COVID-19 serology test
On Jul. 21, 2020, PerkinElmer announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2…
Luminex received FDA Emergency Use Authorization for COVID-19 antibody test
On Jul. 20, 2020, Luminex announced the FDA had issued an Emergency Use Authorization for the company’s xMAPï¾®…
The FDA FDA Issued first Emergency Authorization for sample pooling in diagnostic testing
On Jul. 18, 2020, the FDA reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its…
Heron Therapeutics announced initiation of phase 2 clinical study of CINVANTIï¾® for treatment of COVID-19
On Jul. 16, 2020, Heron Therapeutics announced initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating…
Dynavax announced first participants dosed in phase 1 clinical evaluating Medicagoï¾’s COVID-19 vaccine candidate
On Jul. 14, 2020, Dynavax Technologies announced that the first participants have been dosed in the Phase 1…
Bellerophon Therapeutics announced first patient treated in phase 3 clinical study of INOpulseï¾® inhaled nitric oxide therapy for COVID-19
On Jul. 13, 2020, Bellerophon Therapeutics announced that the first patient has initiated treatment in the Companyï¾’s Phase…
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 companiesï¾’ four investigational vaccine candidates from…
Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulioï¾® (adalimumab-fkjp)
On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the FDA had approved Hulioï¾® (adalimumab-fkjp), a…
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…