Mylan ramped up U.S. manufacturing of hydroxychloroquine sulfate tablets to meet potential COVID-19 patient needs
On Mar. 19, 2020, Mylan announced it had restarted production of hydroxychloroquine sulfate tablets at its West Virginia…
Abbott received FDA Emergency Use Authorization and launches test to detect novel Coronavirus
On Mar. 19, 2020, Abbott announced the FDA has issued Emergency Use Authorization (EUA) for the company’s molecular…
Roche initiated phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia
On Mar. 19, 2020, Roche announced it was working with the U.S. Food & Drug Administration (FDA) to…
FDA approved Epclusa (Sofosbuvir/Velpatasvir) for children with Chronic Hepatitis C infection
On Mar. 19, 2020, Gilead Sciences announced the U.S. Food and Drug Administration (FDA) had approved a supplemental…
Abbott received FDA Emergency Use Authorization and launched test to detect novel Coronavirus
On Mar. 18, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for the company’s…
Biotechnology | COVID-19 | FDA | Therapeutics
Mateon to develop its OT-101, a phase 3 clinical drug candidate against COVID-19
On Mar. 18, 2020, Mateon Therapeutics reported significant progress in deploying its phase 3 clinical asset, OT-101, against…
Eli Lilly and Indiana State Department of Health partnered to accelerate COVID-19 testing using Lilly Research Laboratories
On Mar. 18, 2020, Eli Lilly announced its scientists were partnering with the Indiana State Department of Health…
Biotechnology | COVID-19 | Diagnostics | FDA
Quidel received Emergency Use Authorization for molecular COVID-19 diagnostic assay
On Mar. 17, 2020, Quidel Corp. announced it had received Emergency Use Authorization (EUA) from the U.S. Food…
Latest FDA guidance allows distribution of SARS-CoV-2 serology tests for diagnostic use
On Mar. 17, 2020, BioMedomics announced it will be able to distribute their COVID-19 IgM-IgG Antibody Rapid Test…
Todos Medical announced Coronavirus Nucleic Acid Buccal Testing Kit distribution agreement with 3D BioMed
On Mar. 17, 2020, Todos Medical announced a non-exclusive distribution agreement with 3D Biomedicine Science & Technology, a…
Aimmune announced first U.S. patients treated with PALFORZIA, the first treatment for peanut allergy
On Mar. 16, 2020, Aimmune Therapeutics announced that the first patients in the U.S. were being treated with…
Biotechnology | COVID-19 | Diagnostics | FDA
Hologic’s molecular test for the novel Coronavirus, SARS-CoV-2, receives FDA Emergency Use Authorization
On Mar. 16, 2020, Hologic announced the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization…
Biotechnology | COVID-19 | Diagnostics | FDA
BD, BioGX announced FDA Emergency Use Authorization submissions for new COVID-19 diagnostics for use in U.S.
On Mar. 16, 2020, BD (Becton, Dickinson and Company) announced the companies had submitted Emergency Use Authorization requests…
Roche announced FDA Emergency Use Authorization and availablabilityof cobas SARS-CoV-2 detection test
On Mar. 13, 2020, Roche announced the FDA has issued an Emergency Use Authorization for the cobasﾮ SARS-CoV-2…
FDA issued Emergency Use Authorization to Thermo Fisher Scientific for diagnostic test for COVID-19
On Mar. 13, 2020, Thermo Fisher Scientific announced the FDA has issued an emergency use authorization (EUA) for…
The FDA approved the first treatment for group of progressive interstitial lung diseases
On Mar. 9, 2020, the FDA approved Boehringer Ingelheim’s Ofev (nintedanib) oral capsules to treat patients with chronic…
Biotechnology | Disease | FDA | Therapeutics
The FDA approved new treatment for adults with Cushing’s disease
On Mar. 6, 2020, the FDA approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either…
University of Washington Medicine deployed new test for coronavirus
On Mar. 4, 2020, the UW Medicine Clinical Virology Lab announced it had received U.S. Food and Drug…
Biotechnology | COVID-19 | FDA | Therapeutics
Mateon updated Rapid Antiviral Response Program Initially targeting COVID-19
On Mar. 2, 2020, Mateon Therapeutics reported the company had been evaluating its therapeutic and AI platforms to…
University of Washington Medicine received FDA permission to conduct coronavirus tests
On Feb. 29, 2020, the University of Washington (UW) Medicine Clinical Virology Lab announced it had received U.S….
The FDA approved a generic version of Daraprim for the treatment of toxoplasmosis
On Feb. 28, 2020, the FDA approved an application for the first generic of Daraprim (pyrimethamine) tablets for…
Innovation Pharma submited Material Transfer Agreement to study defensin mimetic Brilacidin for Coronavirus
On Feb. 24, 2020, Innovation Pharmaannounced the Company submitted a Material Transfer Agreement (MTA) with a leading U.S.-based…
FDA | NIH | U.S. Congress
Federal Judge ruled missing clinical trial data must be made public
On Feb. 22, 2020, a federal judge from the Southern District of New York ruled drug companies, device…
The FDA approved non-statin drug to treat high cholesterol
On Feb. 21, 2020, the U.S. Food and Drug Administration (FDA) approved NEXLETOL (bempedoic acid) tablet, an oral,…
Biotechnology | Diagnostics | Disease | FDA | Therapeutics
FDA authorized marketing of first genetic test to aid in diagnosis of Fragile X Syndrome
On Feb. 21, 2020, the U.S. Food and Drug Administration (FDA) authorized marketing of the first test to…
Innovation Pharma’s Brilacidin tested as drug and vaccine at different institutions
On Feb. 18, 2020, Innovation Pharma announced the Company was exploring its lead defensin mimetic drug candidate, Brilacidin,…
US DoD exercised option for IXIARO vaccine for Japanese encephalitis with Valneva
On Jan. 14, 2020, Valneva announced that the U.S. Department of Defense (DoD) had exercised an option to…
FDA approved 3D-printed airway stents developed by Cleveland Clinic doctor
On Jan. 8, 2020, the U.S. Food and Drug Administration (FDA) approved patient-specific airway stents developed by Cleveland…
Biotechnology | FDA | Oncology | Therapeutics
The FDA approved new treatment option for patients with HER2-positive breast cancer
On Dec. 20, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Daiichi Sankyo’s Enhertu…
FDA granted accelerated approval to Astellas and Seagen PADCEV for people with locally advanced or metastatic urothelial cancer
On Dec. 18, 2019, Seagen and Astellas Pharma announced the U.S. Food and Drug Administration (FDA) had granted…