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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,…
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…
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…
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,…
FDA approved new sickle cell treatment based on clincal trial resutls 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…
Biotechnology | CDC | FDA | Life Science News | 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)…
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…
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),…
FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox
On Sept. 24, 2019, the U.S. Food and Drug Administration announced approval of Jynneos Smallpox and Monkeypox Vaccine,…
Genentech drug Polivy (polatuzumab vedotin-piiq) granted accelerated approval by FDA
On Jun. 10, 2019, Genentech drug Polivy (polatuzumab vedotin-piiq) announced the U.S. Food and Drug Administration (FDA) had…
AveXis received FDA approval for gene thereapy drug for Spinal Muscular Atrophy
On May 24, 2019, La Jolla, CA-based AveXis, a subsidiary of Novartis, received U.S. Food and Drug Administration…
FDA authorized marketing of first diagnostic test for detecting Zika virus antibodies
On May 23, 2019, the U.S. Food and Drug Administration (FDA) announced that it had authorized InBios’ marketing…
GSK invested $100 million to expand long-term vaccine manufacturing capabilities in Hamilton
On Apr. 24, 2019, GSK announced $100 million of new investment in its manufacturing site in Hamilton, Montana…
Amgen announced FDA approval of EVENITY for the treatment of osteoporosis
On Apr. 9 2019, Amgen announced U.S. Food and Drug Administration (FDA) approval of EVENITY (romosozumab-aqqg) for the…
The only FDA approved IV antimalarial in the US, IV quinidine, was discontinued
In Mar. 29, 2019, the Centers for Disease Control and Prevention (CDC) issued new guidance to clinicians for…
Biotechnology | Disease | FDA | Life Science News | Oncology | Therapeutics
The FDA approved new formulation of Herceptin for subcutaneous use
On Feb. 28, 2019, the U.S. Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk injection,for subcutaneous use…
FDA approved expanded use of Sanofi’s Adacel Tdap vaccine for a second dose in people ages 10 through 64 years of age
On Jan. 14, 2019, Sanofi announced the FDA had approved the expanded use of Adacelﾮ (Tetanus Toxoid, Reduced…
FDA approved Vaxelis, a new combination DTaP-IPV-Hib-HepB vaccine for use in children 6 wks-4 yrs of age
On Dec. 26, 2018, Sanofi announced the U.S. Food and Drug Administration (FDA) had approved VAXELIS (Diphtheria and…
FDA approved gilteritinib, a targeted drug for leukemia tested at UPenn
On Nov. 28, 2018, The U.S. Food and Drug Administration (FDA) announced it had approved the first ever…
AcelRx pharmaceutical DSUVIA was approved by FDA
On Nov. 2, 2018, AcelRx pharmaceutical’s DSUVIA was approved by U.S. Food and Drug Administration (FDA). DSUVIA is…
FNIH Biomarkers Consortium and Critical Path Institute achieve qualification of a clinical safety biomarker
On Oct. 25, 2018, The Foundation for the National Institutes of Health, Biomarkers Consortium and the Critical Path…
FDA approved expanded use of Gardasil 9 vaccine to include adults 27 through 45 years old
On Oct. 5, 2018, the FDA announced it had approved a supplemental application for Gardasil 9 (Human Papillomavirus…
ReFRAME drug repurposing collection yields hope for treating diseases that kill millions worldwide
On Oct. 3, 2018, Scripps Research announced that Calibr scientitsts from Scripp’s drug development division had bengun using…
Diagnostics | Disease | FDA
InBios received FDA clearance for its DENV detect NS1 ELISA test for early detection of Dengue fever
On Sept. 11, 2018, the U.S. Food and Drug Administration (FDA) had announced that it had received 510k…
Patients, FDA staff, industry leaders and researchers participated in JIA Patient-Focused Drug Development meeting
On Aug. 2, 2018, hundreds of patients and their families, U.S. Food and Drug Administration (FDA) staff, industry…