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…
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Biotechnology | COVID-19 | Diagnostics | FDA
FDA issued Emergency Use Authorization to Thermo Fisher Scientific for diagnostic test for COVID-19
On Mar. 13, 2020, Thermo Fisher Scientific announced the U.S. Food and Drug Administration (FDA) has issued an emergency…
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Biotechnology | CDC | COVID-19 | Diagnostics | FDA | Infectious Disease | NIH | Non-Profit Research | Therapeutics | Vaccine | WHO
National Emergency declared in U.S. for novel Coronavirus disease outbreak
On Mar. 13, 2020, declared a COVID-related emergency under Section 501(b) of the Stafford Act [18]. Under the…
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Roche announced FDA Emergency Use Authorization and availablabilityof cobas SARS-CoV-2 detection test
On Mar. 13, 2020, Roche announced the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization…
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Biotechnology | Disease | FDA | Therapeutics
The FDA approved the first treatment for group of progressive interstitial lung diseases
On Mar. 9, 2020, The U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) oral capsules to treat…
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Biotechnology | Disease | FDA | Therapeutics
The FDA approved new treatment for adults with Cushing’s disease
On Mar. 6, 2020, the U.S. Food and Drug Administration (FDA) approved Isturisa (osilodrostat) oral tablets for adults…
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Innovation Pharma signs second MTA to explore Brilacidin as Coronavirus COVID-19 treatment
On Mar. 6, 2020, Innovation Pharmaceuticals continues to receive inquiries regarding the potential of Brilacidin, the Company’s novel…
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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…
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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…
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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….
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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…
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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…
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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…
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Biotechnology | Disease | FDA | Neurology | Pharmaceutical | Therapeutics
FDA approved Lundbeck’s VYEPTI™ – the first and only intravenous preventive treatment for migraine
On Feb. 21, 2020, Lundbeck announced that VYEPTI™ (eptinezumab-jjmr) had been approved by the U.S. Food and Drug…
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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,…
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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…
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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,…
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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…
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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…
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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…
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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…
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Pediatric brain tumor treatment at the University of Alabama awarded FDA grant for first-in-human study
On Dec. 17, 2019, the University of Alabama at Birmingham Comprehensive Cancer Center (UAB) announced that Gregory Friedman,…
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FDA approved new sickle cell treatment based on clincal trial results from UTHSC’s Kenneth Ataga, MD
On Dec. 2, 2019, the U.S. Food and Drug Administration (FDA) announced it had approved the drug crizanlizumab…
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Biotechnology | CDC | FDA | NIH | Non-Profit Research | Pharmaceutical | Vaccine
CDC published updated ACIP recommendations for use of PCV13 and PPSV23 pneumococcal vaccines for adults age 65 and older
On Nov. 22, 2019, the Centers for Disease Control and Prevention”s (CDC) Advisory Committee on Immunization Practices (ACIP)…
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FDA approved Fluzone High-Dose Quadrivalent for adults 65+ years of age for 2020-21 flu season
On Nov. 4, 2019, the U.S. Food and Drug Administration (FDA) approved Fluzone High-Dose Quadrivalent (Sanofi Pasteur) for…
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Genentech announced FDA approval of antiviral drug Xofluza (Baloxavir Marboxil)
On Oct. 17, 2019, Genentech announced the U.S. Food and Drug Administration (FDA) had approved Xofluza (Baloxavir Marboxil),…
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Bavarian Nordic Announces U.S. FDA Approval of JYNNEOS™ Vaccine for Prevention of Smallpox and Mpox
On Sept. 24, 2019, Bavarian Nordic announced that the U.S. Food and Drug Administration (FDA) had approved JYNNEOS™…
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Genentech drug Polivy (polatuzumab vedotin-piiq) granted accelerated approval by FDA
On Jun. 10, 2019, Genentech announced the U.S. Food and Drug Administration (FDA) had granted accelerated approval to…
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At $2M, priciest ever medicine treats fatal genetic disease
On May 24, 2019, U.S. regulators have approved the most expensive medicine ever, for a rare disorder that destroys…
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Biotechnology | CDC | Diagnostics | FDA | Infectious Disease | Neurology
FDA authorized marketing of first diagnostic test for detecting Zika virus antibodies
On May 23, 2019, the U.S. Food and Drug Administration (FDA) authorized marketing of a diagnostic test to…
