FDA approved targeted treatment for rare Duchenne Muscular Dystrophy mutation
On Aug. 12, 2020, the FDA granted accelerated approval to NS Pharma’s Viltepso (viltolarsen) injection for the treatment…
Hologic launched validated pooling protocol for COVID-19 testing
On Aug. 11, 2020, Hologic announced that it has validated use of its Aptimaﾮ and Panther Fusionﾮ molecular…
COVID-19 | FDA | Therapeutics
Gilead submited New Drug Application to FDA for Veklury (Remdesivir) for treatment of COVID-19
On Aug. 10, 2020, Gilead Sciences announced that it had submitted a New Drug Application (NDA) to the…
Vaxart announced IND filed for COVID-19 vaccine
On Aug. 10, 2020, Vaxart announced that its COVID-19 Investigational New Drug (IND) application has been filed with…
Humanigen expands phase III study of lenzilumab in COVID-19 to Brazil
On Aug. 10, 2020, Humanigen announced that the Brazilian regulatory agency, Anvisa, had granted permission to commence a…
Biotechnology | Disease | FDA | Therapeutics
FDA approved oral treatment for spinal muscular atrophy
On Aug. 7, 2020, the U.S. Food and Drug Administration (FDA) approved Genentech’s Evrysdi (risdiplam) to treat patients…
FDA approved two emergency INDs for COVID-19 outpatient therapy
On Aug. 6, 2020, Organicell Regenerative Medicine announced that the FDA had approved two outpatient Emergency Investigational New…
Johnson & Johnson announces agreement with US Government for 100 million doses of investigational COVID-19 vaccine
On Aug. 5, 2020, Johnson & Johnson announced a $1 billion agreement with the U.S. government for the…
Biotechnology | COVID-19 | Diagnostics | FDA
Precipio launched Covid-19 antibody test in its CLIA laboratory
On Aug. 4, 2020, Precipio announced it had completed the internal validation of the U.S. Food and Drug…
FDA issued Emergency Use Authorization for Impella heart pumps to provide unloading therapy to COVID-19 patients
On Aug. 4, 2020, Abiomed announced the FDA had issued an emergency use authorization (EUA) for its left-sided…
FDA approved new indication for drug containing an active Cannabis ingredient to treat seizures in rare genetic disease
On Jul. 31, 2020, the U.S. Food and Drug Administration (FDA) announced it had approved Epidiolex (cannabidiol) [CBD]…
OraSure’s OMNIgene-ORAL device included in EUA granted to Clinical Reference Laboratory for self-collected SARS saliva test
On Jul. 31, 2020, OraSure Technologies announced that its OMNIgene-ORAL (OM-505) saliva collection device is included in the…
Biotechnology | COVID-19 | FDA
Precipio announced commercial launch of Covid-19 antibody test
On Jul. 30, 2020, Precipio announced it had entered into an agreement with ADS Biotec, based in Omaha,…
LabCorp announced work wth public health authorities on no-charge antibody test program to accelerate COVID-19 blood plasma donation
On Jul. 30, 2020, LabCorpﾮ launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital…
FDA authorized Quest Diagnostics lab method designed to increase COVID-19 molecular diagnostics capacity
On Jul. 29, 2020, Quest Diagnostics announced that the FDA had granted emergency use authorization for a new…
BARDA procured Regeneron’s REGN-EB3 investigational Ebola treatment for national preparedness
On Jul. 29, 2020, Regeneron announced that the Biomedical Advanced Research and Development Authority (BARDA) had entered into…
LabCorp received authorization for COVID-19 sample pooling
On Jul. 25, 2020, LabCorpﾮ announced it received an Emergency Use Authorization from the FDA permitting diagnostic testing…
Biotechnology | COVID-19 | FDA
Dynavax and Medigen announced collaboration to develop a novel adjuvanted COVID-19 vaccine candidate
On Jul. 23, 2020, Dynavax Technologies and Medigen Vaccine Biologics announced their collaboration to develop an adjuvanted vaccine…
Biotechnology | COVID-19 | FDA | Medicine | Therapeutics | Vaccine
Medigen Vaccines collaborated with Dynavax to develop novel adjuvanted COVID-19 vaccine candidate
On Jul. 23, 2020, Dynavax Technologies and Medigen Vaccine Biologics (MVC) announced a collaboration to develop an adjuvanted…
Findings from real-world data study reveal higher risk of hospitalization and death among cancer patients with COVID-19
On Jul. 22, 2020, the FDA announced the data analyzed in collaboration with Syapse revealed a stark reality…
BD received FDA approval for HPV test with extended genotyping capabilities
On Jul. 22, 2020, BD (Becton, Dickinson) announced that it had received approval for a pre-market approval (PMA)…
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 xMAPﾮ…
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 CINVANTIﾮ 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 Medicagoﾒ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 INOpulseﾮ inhaled nitric oxide therapy for COVID-19
On Jul. 13, 2020, Bellerophon Therapeutics announced that the first patient has initiated treatment in the Companyﾒ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 companiesﾒ four investigational vaccine candidates from…
Mylan and Fujifilm Kyowa Kirin Biologics announced FDA approval of Hulioﾮ (adalimumab-fkjp)
On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the FDA had approved Hulioﾮ (adalimumab-fkjp), a…