FDA updated mmammography regulations to require reporting of breast density information and facility oversight
On Mar. 9, 2023, the U.S. Food and Drug Administration announced that it had published updates to the…
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…
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….
FDA grants Lenireï¾® Tinnitus treatment device de novo approval
On Mar. 6, 2023, Neuromod Devices announced that the US Food and Drug Administration (FDA) had granted De…
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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 had approved the addition of…
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…
U.S. Government and Novavax extend partnership for 1.5 million additional doses of Novavax’ COVID-19 vaccine
On Feb. 23, 2023, Novavax announced a modification to its existing agreement with the U.S. Department of Health…
FDA authorized first Mpox test
On Feb. 10, 2023, the U.S. Food and Drug Administration issued an emergency use authorization for the first…
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…
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 Actemraï¾® (tocilizumab)…
Biotechnology | COVID-19 | FDA | Influenza | Life Science News | 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….
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…
Biotechnology | COVID-19 | FDA | Life Science News | 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…
FDA accepted for Priority Review the BLA for Pfizerï¾’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…
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…
FDA finalized historic rule enabling access to Over-the-Counter hearing aids for millions of Americans
On Oct. 19, 2022, the U.S. Food and Drug Administration final rule establishing Over-the-Counter Hearing Aids to improve…
U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults
On Oct. 19, 2022, the U.S. FDA recommended the use of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as…
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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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…
Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age
On Sept. 28, 2022, Pfizer and BioNTech announced they have completed a submission to the U.S. Food and…
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…
Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccine
On Aug. 23, 2022, Moderna announced that it has completed its submission to the U.S. Food and Drug…
Pfizer and BioNTech submitted application to U.S. FDA for EUA of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
On Aug. 22, 2022, Pfizer and BioNTech announced they had completed a submission to the U.S. Food and…
U.S. Department of Health and Human Services made more vaccine doses available to support Monkeypox response
On Aug. 15, 2022, the U.S. Department of Health and Human Services announced that was making up to…
Pfizer announced submission of New Drug Application to the U.S. FDA for PAXLOVID
On Jun. 30 2022, Pfizer announced the submission of a New Drug Application (NDA) to the U.S. Food…
Pfizer and BioNTech announced agreement with U.S. Government to provide additional doses of COVID-19 Vaccine
On Jun. 30, 2022, Pfizer and BioNTech announced a vaccine supply agreement with the U.S. government to support…
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COVID-19 Wheel of Fortune
Play the COVID-19 Wheel of Fortune and see how lucky you are! You have two wheels to choose…
Emergent BioSolutions announced FDA acceptance of Biologics License Application for AV7909 Anthrax vaccine candidate
On Jun. 24, 2022, Emergent BioSolutions announced that the U.S. Food and Drug Administration accepted for review the…
U.S. FDA approved Merck’s VAXNEUVANCE for prevention of invasive pneumococcal disease in infants and children
On Jun. 22, 2022, Merck announced that that the U.S. Food and Drug Administration (FDA) had approved an…
Veru submitted EUA to U.S. FDA for Sabizabulin, its anti-Inflammatory drug candidate for hospitalized COVID-19 patients
On Jun. 7, 2022, Veru announced that is had submitted an emergency use authorization (EUA) application to the…