FDA approved first oral treatment for moderately to severely active Crohn’s disease
On May 18, 2023, the U.S. Food and Drug Administration (FDA) approved approved Rinvoq (upadacitinib) for adults with moderately…
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Biotechnology | Disease | FDA | Neurology | Therapeutics
FDA approved first drug to treat agitation symptoms associated with dementia due to Alzheimer’s disease
On May 11, 2023, the U.S. Food and Drug Administration (FDA) announced the supplemental approval of Otsuka Pharmaceutical…
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FDA Approved First University-made Sausage from Gene-edited Pigs
On May 3, 2023, Washington State University (WSU) made history in the United States (US) by becoming the…
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U.S. FDA approved first Respiratory Syncytial Virus (RSV) vaccine
On May 3, 2023, the U.S. FDA approved GlaxoSmithKline’s Arexvy as the first respiratory syncytial virus (RSV) vaccine…
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Vertex announced U.S. FDA approval for KALYDECO to treat eligible Infants with cystic fibrosis ages 1 month and older-First and only CFTR modulator approved for this age group
On May 3, 2023, Vertex announced the Food and Drug Administration (FDA) had approved KALYDECO (ivacaftor) for use…
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Biotechnology | Clinical Research | Diagnostics | FDA | Infectious Disease | NIH | Therapeutics | Vaccine | Women's Health
U.S. FDA announced additional steps to advance decentralized clinical trials
On May 2, 2023, the U.S. Food and Drug Administration (FDA) announced that it was taking additional steps…
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Biotechnology | FDA | Therapeutics | Vaccine
U.S. FDA approved PREVNAR 20, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children
On Apr. 27, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®…
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Biotechnology | Disease | FDA | Therapeutics
Vertex announced U.S. FDA approval for TRIKAFTA in children with cystic fibrosis ages 2 through 5 with certain mutations
On Apr. 26, 2023, Vertex announced the Food and Drug Administration (FDA) had approved the expanded use of…
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U.S. FDA approved treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
On Apr. 25, 2023, the U.S. U.S. Food and Drug Administration (FDA announced it had approved Qalsody (tofersen) to…
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U.S. FDA issued Emergency Use Authorization for new COVID-19 Over-the-Counter at-home antigen test
On Apr. 24, 2023, the U.S. Food and Drug Administration (FDA) authorized Status COVID-19 Antigen Rapid Test for…
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Biotechnology | FDA | Oncology | Radiology | Stem Cell
U.S. FDA approves cell therapy for patients with blood cancers to reduce risk of infection after stem cell transplantation
On Apr. 17, 2023, the U.S. Food and Drug Administration (FDA) approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially…
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U.S. FDA Approved First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for the Treatment of Cervical Dystonia
On Apr. 14, 2023, Revance Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved the…
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FDA | Implants | Orthopedic
FDA authorizes marketing of MISHA Knee System for people Suffering from knee osteoarthritis
On Apr. 10, 2023, the U.S. Food and Drug Administration (FDA) authorized for marketing Moximed’s MISHA Knee System,…
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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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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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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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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….
