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 FDAﾒ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 | 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…
Biotechnology | COVID-19 | Diagnostics | FDA
InBios received FDA Emergency Use Authorization for COVID-19 antibody test
On Jun. 11, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the U.S. Food…
FDA approved Bristol-Myers’ Opdivo’ (nivolumab) for treatment of patients with advanced esophageal squamous cell carcinoma
On Jun. 11, 2020, Bristol-Myers Squibb announced that Opdivo (nivolumab) was approved by the FDA for the treatment…
The FDA approved new therapy for rare disease affecting optic nerve, spinal cord
On Jun. 11, 2020, the FDA approved Viela Bio’s Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment…
Moderna advanced late-stage development of vaccine (mRNA-1273) against COVID-19
On Jun. 11, 2020, Moderna announced progress on late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against…
The FDA authorized first next generation sequence test for diagnosing COVID-19
On Jun. 10, 2020, the FDA issued an emergency use authorization (EUA) to Illumina for the first COVID-19…
Biotechnology | Diagnostics | FDA | Genomics
Illumina received first FDA Emergency Use Authorization for sequencing-based COVID-19 diagnostic test
On Jun. 9, 2020, Illumina announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization…
Biotechnology | COVID-19 | FDA
Quidel’s received amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay
On Jun. 9, 2020, Quidel announced it had received an amended Emergency Use Authorization (EUA) from the FDA,…
Immunic announced FDA allowance of its phase 2, CALVID-1 clinical trial of IMU-838 in COVID-19
On Jun. 9, 2020, Immunic announced receipt of regulatory allowance from the FDA to initiate its phase 2,…
OraSure’s Oragene-Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test
On Jun. 8, 2020, OraSure Technologies announced that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for…
The FDA approved antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
On Jun. 4, 2020, the FDA approved Merck’s Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired…
FDA cleared IND for iNKT Cells to treat COVID-19 patients
On Jun. 2, 2020, Agenus announced the FDA’s clearance of AgenTus’ IND application for an allogeneic iNKT therapy….
FDA issued Emergency Use Authorization for Impella RP as therapy for COVID-19 patients with right heart failure
On Jun. 1, 2020, the FDA issued an emergency use authorization (EUA) for Impella RP to include patients…
Altimmune launched clinical trial of T-COVIDTM, an investigational intranasal immune modulator for treatment of patients with early COVID-19
On Jun. 1, 2020, Altimmune announced the FDA had authorized the Company to proceed with a clinical trial…
FDA authorized OPKO Health clinical trial evaluating RAYALDEE in COVID-19 patients
On Jun. 1, 2020, OPKO Health announced the FDA had authorized OPKO to undertake a Phase 2 trial…
The FDA streamlined development of tests with at-home sample collection
On May 29, 2020, the FDA took steps to further support the development of COVID-19 tests for at-home…
The FDA approved first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
On May 28, 2020, the FDA approved Avid Radiopharmaceuticals’ Tauvid (flortaucipir F18) for intravenous injection, the first drug…
FDA authorized Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for emergency use
On May 28, 2020, Quest Diagnostics announced it had received emergency use authorization (EUA) from the FDA for…
The FDA approved only drug in U.S. to treat severe malaria
On May 26, 2020, the FDA approved Amivas’ artesunate for injection to treat severe malaria in adult and…