Moderna announced FDA authorization of booster dose of COVID-19 vaccine in the U.S.
On Oct. 20, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized for emergency…
Johnson & Johnson COVID-19 vaccine booster shot authorized for Emergency Use by U.S. FDA
On Oct. 20, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued Emergency…
FDA approved naloxone injection to counteract opioid overdoses
On Oct. 18, 2021, the Food and Drug Administration approved ZIMHI (naloxone hydrochloride) injection as an additional option…
Biotechnology | FDA | HIV | Therapeutics
U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populations
On Oct. 18, 2021, Gilead Sciences announced that the Food and Drug Administration had approved a new low-dose…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
On Oct. 15, 2021, Roche announced that the U.S. Food and Drug Administration (FDA) had approved Tecentriq (atezolizumab)…
Moderna announced FDA Advisory Committee unanimously voted in support of EUA for booster dose of COVID-19 vaccine
On Oct. 14, 2021, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
FDA accepted REGEN-COVﾮ (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
On Oct. 14, 2021, Regeneron announced that the U.S. Food and Drug Administration (FDA) had accepted for priority…
Merck and Ridgeback announced Submission of EUA to the FDA for Molnupiravir, an Investigational Oral antiviral medicine, for treatment of COVID-19
On Oct. 11, 2021, Merck and Ridgeback Biotherapeutics announced that Merck had submitted an Emergency Use Authorization (EUA)…
PerkinElmer received FDA Emergency Use Authorization for respiratory SARS-CoV-2 panel
On Oct. 7, 2021, PerkinElmer announced that the U.S. Food and Drug Administration (FDA) had issued Emergency Use…
COVID-19 | Diagnostics | FDA
EUROIMMUN anti-SARS-CoV-2 S1 curve ELISA received FDA Emergency Use Authorization
On Oct. 5, 2021, PerkinElmer announced that the U.S. Food and Drug Administration had provided Emergency Use Authorization…
Johnson & Johnson submitted EUA amendment to FDA to support booster of single-shot COVID-19 vaccine
On Oct. 5, 2021, Johnson & Johnson announced it had submitted data to the U.S. Food and Drug…
Merck and Ridgeback’s oral antiviral reduced risk of hospitalization or death for patients with COVID-19 in positive phase 3 study
On Oct. 1, 2021, Merck and Ridgeback Biotherapeutics announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine,…
FDA approved Kiteﾒs Tecartusﾮ as first and only Car T for adults with Relapsed or Refractory B-cell ALL
On Oct. 1, 2021, Kite, a Gilead Company, announced the U.S. Food and Drug Administration had granted approval…
U.S. FDA cleared Naeotom Alpha, worldﾒs first photon-counting computer tomograph
On Sept. 30 2021, Siemens Healthineers announced the Food and Drug Administration (FDA) 510 (k) clearance of the…
Pfizer reported positive top-line results of phase 3 study exploring coadministration of Prevnar 20 With seasonal Flu vaccine
On Sept. 29, 2021, Pfizer and BioNTech announced they had submitted data to the U.S. Food and Drug…
Pfizer and BioNTech submitted initial data to FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
On Sept. 28, 2021, Pfizer and BioNTech announced they had submitted data to the U.S. Food and Drug…
Pfizer and BioNTech received first U.S. FDA Emergency Use Authorization of a COVID-19 vaccine booster
On Sept. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) has authorized…
OraSure received $13.6 million from BARDA to support InteliSwab COVID-19 rapid test 510(k) Clearance and CLIA Waiver
On Sept. 23, 2021, OraSure Technologies and the Biomedical Advanced Research Development Authority (BARDA) announced up to $13.6…
Biotechnology | COVID-19 | Diagnostics | FDA
InBios received FDA EUA for COVID-19 IgG antibody rapid test
On Sept. 15, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
FDA declined Humanigenﾒs Emergency Use Authorization request for lenzilumab in hospitalized COVID-19 patients
On Sept. 9, 2021, Humanigen announced the U.S. FDA had declined its request for emergency use authorization of…
AIM ImmunoTech submitted pre-IND application to FDA for phase 2 clinical study of Ampligen for post-COVID-19 cognitive dysfunction
On Sept. 8, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to…
Biotechnology | COVID-19 | FDA | Pharmaceutical | Therapeutics | Vaccine
Pfizer and BioNTech submitted a variation to EMA with data in support of a booster dose of COMIRNATY
On Sept. 6, 2021, Pfizer and BioNTech announced that they had submitted a variation to the European Medicines…
Moderna announced submission of initial data to U.S. FDA for Its COVID-19 vaccine booster
On Sept. 1, 2021, Moderna announced it had initiated its submission to the U.S. Food and Drug Administration…
Moderna completed submission of BLA to the Food and Drug Administration for its COVID-19 vaccine
On Aug. 25, 2021, Moderna announced it had completed the rolling submission process for its Biologics License Application…
COVID-19 | Diagnostics | FDA | Medical Device
BD received EUA for first at-home COVID-19 test to use smartphone to interpret, deliver results
On Aug. 25, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had issued an…
Pfizer and BioNTech initiated rolling submission of SBLA to U.S. FDA for booster dose of COMIRNATY in individuals 16 and Older
On Aug. 25, 2021, Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to…
U.S. FDA approved first COVID-19 vaccine
On Aug. 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine, known…
Pfizer-BioNTech COVID-19 vaccine COMIRNATY received full U.S. FDA approval for individuals 16 years and older
On Aug. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…
Pfizer and BioNTech announced submission of initial data to FDA to support booster dose of COVID-19 vaccine
On Aug. 16, 2021, Pfizer and BioNTech announced that they had submitted Phase 1 data to the U.S….
ADMA Biologics received FDA approval for plasma collection facility in Maryville, TN
On Aug. 16, 2021, ADMA Biologics announced that it had received U.S. Food and Drug Administration approval for…