U.S. FDA approved first Over-the-Counter Naloxone nasal spray
On Mar. 29, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Narcan, 4 milligram naloxone…
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National Science Foundation released reports outlining bold goals for U.S. bioeconomy
On Mar. 22, 2023, the White House Office of Science and Technology Policy released a series of five…
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FDA authorized bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
On Mar. 14, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of…
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Pfizer’s ZAVZPRET (zavegepant) Migraine Nasal Spray received FDA approval
On Mar. 10, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ZAVZPRET (zavegepant),…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics | Women's Health
FDA updated mammography regulations to require reporting of breast density information and facility oversight
On Mar. 9, 2023, the U.S. Food and Drug Administration (FDA) announced that it had published updates to…
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Amphastar Pharmaceuticals received FDA approval for Naloxone hydrochloride nasal spray
On Mar. 8, 2023, Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had granted approval…
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Biotechnology | COVID-19 | FDA
QuidelOrtho received de novo FDA authorization for Sofia 2 SARS Antigen+ FIA
On Mar. 8, 2023, QuidelOrtho announced that it had been granted a De Novo request from the U.S….
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FDA grants Lenire Tinnitus treatment device de novo approval
On Mar. 6, 2023, Neuromod Devices announced that the U.S. Food and Drug Administration (FDA) had granted De…
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Biotechnology | FDA | Infectious Disease | Measles | Vaccine
U.S. FDA approved intramuscular administration for Merck’s MMRV Vaccines: M-M-RII, VARIVAX, and ProQuad
On Mar. 6, 2023, Merck announced that the U.S. Food and Drug Administration (FDA) had approved the addition…
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Pfizer and BioNTech submitted for U.S. EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 booster in children under 5 years
On Mar. 1, 2023, BioNTech and Pfizer announced that they had submitted an application to the U.S. Food…
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U.S. Government and Novavax extend partnership for 1.5 million additional doses of Novavax’ COVID-19 vaccine
On Feb. 13, 2023, Novavax announced a modification to its existing agreement with the U.S. Department of Health…
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FDA authorized first Mpox point-of-care test
On Feb. 10, 2023, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…
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Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | Influenza | Vaccine
BD received FDA EUA for COVID-19, influenza A/B, RSV combination test
On Feb. 8, 2023, BD announced that it had received Emergency Use Authorization from the U.S. Food and…
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Agriculture | Biotechnology | Cartoons - Original | COVID-19 | CRISPR | Diagnostics | Disease | FDA | Genomics | Life Science History | Therapeutics | USDA
Milestones in CRISPR
The Milestones in CRISPR cartoon illustrates several significant achievements in the development of the technology with commentary by…
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Biotechnology | FDA | Oncology | Therapeutics
The FDA approves Genentech’s updated drug labeling for Xeloda (capecitabine) under Project Renewal Pilot Program
On Dec. 24, 2022, the U.S. Food and Drug Administration (FDA) approved updated labeling for Genentech’s capecitabine tablets…
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FDA approved Roche’s Actemra for treatment of COVID-19 in hospitalised adults
On Dec. 21, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had approved Actemraﾮ (tocilizumab)…
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Biotechnology | COVID-19 | FDA | Influenza | Vaccine
Pfizer and BioNTech received U.S. FDA Fast Track Designation for single-dose mRNA-based vaccine candidate against COVID-19 and influenza
On Dec. 9, 2022, Pfizer and BioNTech announced the companies had received Fast Track Designation from the U.S….
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Biotechnology | FDA | Oncology | Therapeutics
FDA granted approval to atezolizumab for alveolar soft part sarcoma
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) approved Genentech’s atezolizumab (Tecentriq) for adult and…
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Biotechnology | COVID-19 | FDA | Vaccine
Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children
On Dec. 8, 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration had granted Emergency Use…
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FDA accepted for Priority Review the BLA for Pfizerﾒs Respiratory Syncytial Virus Vaccine candidate for prevention of RSV disease in older adults
On Dec. 7, 2022, Pfizer announced that the U.S. Food and Drug Administration (FDA) had accepted for priority…
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Pfizer and BioNTech submit application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children under 5 years
On Dec. 5, 2022, Pfizer and BioNTech announced that the companies had submitted an application to the U.S….
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Biotechnology | Disease | FDA | Therapeutics
FDA approved first drug that can delay onset of Type 1 Diabetes
On Nov. 17, 2022, the U.S. Food and Drug Administration (FDA) approved Tzield (teplizumab-mzwv) injection to delay the…
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Roche received U.S. FDA Emergency Use Authorization for its high-throughput test to detect mpox virus
On Nov. 15, 2022, Roche announced that the U.S. Food and Drug Administration (FDA) had granted Emergency Use…
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INOVIO Discontinued internal efforts to develop INO-4800 as COVID-19 heterologous booster vaccine Candidate
On Oct. 27, 2022, Inovio Pharma announced that it has discontinued its internally funded efforts to develop INO-4800…
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U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults
On Oct. 19, 2022, Novavax announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization…
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Moderna received Authorization for Emergency Use from FDA of Omicron-targeting bivalent COVID-19 booster vaccine for children
On Oct. 12, 2022, Moderna announced that it had received emergency use authorization from the U.S. Food and…
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Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | Vaccine
Pfizer and BioNTech received U.S. FDA EUA for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children
On Oct. 12, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration granted Emergency Use…
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FDA Authorized PCR-Based Mpox Test
On Oct. 7, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to…
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Diagnostics | FDA | NIH | Oncology
U.S. recorded steady decline in cancer death rates
On Sept. 21, 2022, the American Association for Cancer Research (AACR) released the 12th edition of its AACR…
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Biotechnology | Cosmetic | FDA | Therapeutics
FDA Approved Daxxify, a New Anti-Wrinkle Drug
On Sept. 7, 2022, the U.S. Food and Drug Administration (FDA) announced it had approved Revance Therapeutics’ DAXXIFY…
