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 Adacelï¾® (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…
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…
Golden Rice Approved by U.S. FDA
On May 24, 2018, the United States Food and Drug Administration (U.S. FDA) released a statement on GR2E…
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…
Partner Therapeutics acquired Sanofi’s Leukine and Lynnwood manufacturing facility
On Mar. 9, 2018, Boston-based cancer company Partner Therapeutics announced that it had acquired the global rights to…
FDA published guidance to industry known as the “red book”
On Jan. 31, 2018, the FDA published the first Red Book, the successor to 1949 “black book,” officially…
FDA | Influenza | Life Science News | Vaccine
FDA approved expanded pediatric age indication for Fluarix Quadrivalent influenza vaccine
On Jan. 11, 2018, the U.S. Food and Drug Administration (FDA) approved an expanded indication for the four-strain…
Biotechnology | CDC | Diagnostics | FDA | Infectious Disease | Influenza | Life Science News | U.S. Congress | Vaccine | Veterinary
Experts decried lack of flu pandemic readiness, commitment
On Jan. 9, 2018, armed with 1940s-vintage flu vaccine technology and supported by only anemic funding for developing…
Ozempic (semaglutide) was approved in the U.S.
On Dec. 5, 2017, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had approved Ozempic…
Biotechnology | Disease | FDA | Life Science News | Oncology | Therapeutics
FDA approved first biosimilar for the treatment of certain breast and stomach cancers
On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar…
Genentech drug Hemlibra (emicizumab-kxwh) was approved
On Nov. 16, 2017, the the U.S. Food and Drug Administration (FDA) approved the Genentech drug Hemlibra (emicizumab-kxwh)…
FDA licensed Heplisav-B, the new hepatitis B vaccine from Dynavax, for use in adults age 18 and older
On Nov. 9, 2017, the FDA licensed Heplisav-B, the new hepatitis B vaccine, to Berkeley-based Dynavax Technologies for…