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Home / FDA - Page 26

FDA

FDA authorized marketing of first genetic test to aid in diagnosis of Fragile X Syndrome
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…

Read More FDA authorized marketing of first genetic test to aid in diagnosis of Fragile X SyndromeContinue

Innovation Pharma’s Brilacidin tested as drug and vaccine at different institutions
FDA | Life Science History

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,…

Read More Innovation Pharma’s Brilacidin tested as drug and vaccine at different institutionsContinue

US DoD exercised option for IXIARO vaccine for Japanese encephalitis with Valneva
Biotechnology | FDA | Non-Profit Research | Therapeutics | Vaccine

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…

Read More US DoD exercised option for IXIARO vaccine for Japanese encephalitis with ValnevaContinue

FDA approved 3D-printed airway stents developed by Cleveland Clinic doctor
FDA | Medical Device | Therapeutics

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…

Read More FDA approved 3D-printed airway stents developed by Cleveland Clinic doctorContinue

The FDA approved new treatment option for patients with HER2-positive breast cancer
Biotechnology | FDA | Oncology | Therapeutics

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…

Read More The FDA approved new treatment option for patients with HER2-positive breast cancerContinue

FDA granted accelerated approval to Astellas and Seagen PADCEV for people with locally advanced or metastatic urothelial cancer
Biotechnology | FDA | Therapeutics

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…

Read More FDA granted accelerated approval to Astellas and Seagen PADCEV for people with locally advanced or metastatic urothelial cancerContinue

Pediatric brain tumor treatment at the University of Alabama awarded FDA grant for first-in-human study
Biotechnology | FDA | Neurology | Therapeutics

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,…

Read More Pediatric brain tumor treatment at the University of Alabama awarded FDA grant for first-in-human studyContinue

FDA approved new sickle cell treatment based on clincal trial resutls from UTHSC’s Kenneth Ataga, MD
Disease | FDA | Non-Profit Research | Therapeutics

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…

Read More FDA approved new sickle cell treatment based on clincal trial resutls from UTHSC’s Kenneth Ataga, MDContinue

CDC published updated ACIP recommendations for use of PCV13 and PPSV23 pneumococcal vaccines for adults age 65 and older
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)…

Read More CDC published updated ACIP recommendations for use of PCV13 and PPSV23 pneumococcal vaccines for adults age 65 and olderContinue

FDA approved Fluzone High-Dose Quadrivalent for adults 65+ years of age for 2020-21 flu season
FDA | Influenza

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…

Read More FDA approved Fluzone High-Dose Quadrivalent for adults 65+ years of age for 2020-21 flu seasonContinue

Genentech announced FDA approval of antiviral drug Xofluza (Baloxavir Marboxil)
Biotechnology | FDA | Infectious Disease | Influenza | Therapeutics

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),…

Read More Genentech announced FDA approval of antiviral drug Xofluza (Baloxavir Marboxil)Continue

FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox
FDA | Life Science History

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,…

Read More FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypoxContinue

Genentech drug Polivy (polatuzumab vedotin-piiq) granted accelerated approval by FDA
Biotechnology | FDA

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…

Read More Genentech drug Polivy (polatuzumab vedotin-piiq) granted accelerated approval by FDAContinue

AveXis received FDA approval for gene thereapy drug for Spinal Muscular Atrophy
FDA | Life Science History

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…

Read More AveXis received FDA approval for gene thereapy drug for Spinal Muscular AtrophyContinue

FDA authorized marketing of first diagnostic test for detecting Zika virus antibodies
Diagnostics | FDA

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…

Read More FDA authorized marketing of first diagnostic test for detecting Zika virus antibodiesContinue

GSK invested $100 million to expand long-term vaccine manufacturing capabilities in Hamilton
Biotechnology | FDA | Infectious Disease | Vaccine

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…

Read More GSK invested $100 million to expand long-term vaccine manufacturing capabilities in HamiltonContinue

Amgen announced FDA approval of EVENITY for the treatment of osteoporosis
Biotechnology | FDA | Therapeutics

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…

Read More Amgen announced FDA approval of EVENITY for the treatment of osteoporosisContinue

The only FDA approved IV antimalarial in the US, IV quinidine, was discontinued
FDA | Non-Profit Research | Therapeutics

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…

Read More The only FDA approved IV antimalarial in the US, IV quinidine, was discontinuedContinue

The FDA approved new formulation of Herceptin for subcutaneous use
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…

Read More The FDA approved new formulation of Herceptin for subcutaneous useContinue

FDA approved expanded use of Sanofi’s Adacel Tdap vaccine for a second dose in people ages 10 through 64 years of age
FDA | Life Science History

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…

Read More FDA approved expanded use of Sanofi’s Adacel Tdap vaccine for a second dose in people ages 10 through 64 years of ageContinue

FDA approved Vaxelis, a new combination DTaP-IPV-Hib-HepB vaccine for use in children 6 wks-4 yrs of age
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…

Read More FDA approved Vaxelis, a new combination DTaP-IPV-Hib-HepB vaccine for use in children 6 wks-4 yrs of ageContinue

FDA approved gilteritinib, a targeted drug for leukemia tested at UPenn
Biotechnology | FDA | Therapeutics

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…

Read More FDA approved gilteritinib, a targeted drug for leukemia tested at UPennContinue

AcelRx pharmaceutical DSUVIA was approved by FDA
Biotechnology | FDA | Therapeutics

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…

Read More AcelRx pharmaceutical DSUVIA was approved by FDAContinue

FNIH Biomarkers Consortium and Critical Path Institute achieve qualification of a clinical safety biomarker
Biotechnology | Diagnostics | FDA | Non-Profit Research

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…

Read More FNIH Biomarkers Consortium and Critical Path Institute achieve qualification of a clinical safety biomarkerContinue

FDA approved expanded use of Gardasil 9 vaccine to include adults 27 through 45 years old
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…

Read More FDA approved expanded use of Gardasil 9 vaccine to include adults 27 through 45 years oldContinue

ReFRAME drug repurposing collection yields hope for treating diseases that kill millions worldwide
Biotechnology | FDA | Infectious Disease | Non-Profit Research

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…

Read More ReFRAME drug repurposing collection yields hope for treating diseases that kill millions worldwideContinue

InBios received FDA clearance for its DENV detect NS1 ELISA test for early detection of Dengue fever
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…

Read More InBios received FDA clearance for its DENV detect NS1 ELISA test for early detection of Dengue feverContinue

Patients, FDA staff, industry leaders and researchers participated in JIA Patient-Focused Drug Development meeting
FDA | Life Science History

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…

Read More Patients, FDA staff, industry leaders and researchers participated in JIA Patient-Focused Drug Development meetingContinue

FDA approved first drug comprised of an active ingredient derived from marijuana to treat epilepsy
Agriculture | Biotechnology | Disease | FDA | Life Science History | Therapeutics

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…

Read More FDA approved first drug comprised of an active ingredient derived from marijuana to treat epilepsyContinue

Golden Rice Approved by U.S. FDA
Agriculture | Biotechnology | FDA | Life Science History

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…

Read More Golden Rice Approved by U.S. FDAContinue

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