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…
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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…
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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…
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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…
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Biotechnology | Disease | FDA | 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…
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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…
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Biotechnology | FDA | Infectious Disease | Polio | Vaccine
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…
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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…
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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…
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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…
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Biotechnology | FDA | Vaccine
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…
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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 begun using…
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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…
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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…
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FDA approved first drug comprised of an active ingredient derived from marijuana to treat epilepsy
On Jun. 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex (cannabidiol) [CBD] oral solution for…
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Golden Rice Approved by U.S. FDA
On May 24, 2018, the U.S. Food and Drug Administration (FDA) released a statement on GR2E Golden Rice,…
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AquAdvantage announced FDA approval of first U.S. facility for commercial production of AquAdvantage Salmon
On Apr. 27, 2018, AquaBounty Technologies announced that it had received approval from the U.S. Food and Drug…
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Biotechnology | FDA | Oncology | Therapeutics
Partner Therapeutics acquired Sanofi’s Leukine and Lynnwood manufacturing facility
On Mar. 9, 2018, Boston-based cancer company Partner Therapeutics announced that it has acquired the global rights to develop,…
