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…
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…
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…
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 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 | 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 | 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…
Disease | FDA | Therapeutics
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, Dynavax Technologies announced that the U.S. Food and Drug Administration (FDA) had approved HEPLISAV-B…
FDA licensed Shingrix, the new shingles vaccine from GlaxoSmithKline, for use in adults age 50 and older
On Oct. 23, 2017, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) had approved Shingrix (Zoster Vaccine…
FDA approval brought first gene therapy to the U.S.
On Aug. 30, 2017, the U.S. Food and Drug Administration (FDA) approved Kymriah (tisagenlecleucel) for certain pediatric and…
Biotechnology | Disease | FDA | Neurology | Therapeutics
Adamas announced FDA approval of GOCOVRI as first and only medication fortreatment of Dyskinesia in Parkinson’s disease Patients
On Aug. 24, 2017, Adamas announced U.S. Food and Drug Administration (FDA) approval of GOCOVRI as First and…
Seqirus announced major advances in pandemic preparedness
On Aug. 7, 2017, Seqirus announced that the accelerated development of cell-based manufacturing technology at its state-of-the-art manufacturing…
Biotechnology | FDA | Therapeutics | Vaccine
The FDA unveiled a strategic plan to completely eliminate the agency’s existing orphan designation backlog
On Jun. 29, 2017, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to completely eliminate…
The FDA approved Endari developed by Dr Yutaka Niihara at LA Biomed
On Jun. 7, 2017 the FDA approved Endari (L-glutamine oral powder) for patients age five years and older…
Genentech drug Ocrevus (ocrelizumab) was approved
On Mar. 28, 2017, Genentech drug Ocrevus (ocrelizumab) was approved by the U.S. Food and Drug Administration (FDA)…
First drug approved by the FDA for treatment of canine lymphoma
On Jan. 3, 2017, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced the conditional…
FDA approved extending the age range for use of FluLaval Quadrivalent to include children 6 to 35 months of age
On Nov. 18, 2016, the U.S. Food and Drug Administration (FDA) approved extending the age range for use…
Roswell Park study brought Cuban lung cancer vaccine to U.S. Patients
On Oct. 27, 2016, Roswell Park Cancer Institute announced it had received authorization from the U.S. Food and…
Biotechnology | Chemical | Disease | FDA | Oncology | Therapeutics
Genentech drug Tecentriq (atezolizumab) was approved
On Oct. 18, 2016, the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of…
Seqirus received FDA approval for AFLURIA® QUADRIVALENT (Influenza Vaccine) for people 18 years of age and older
On Aug. 29, 2016, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved AFLURIA® QUADRIVALENT…