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2076 News Found

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment
Biotech | September 26, 2021

SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment

Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors


Health Sensei wins Stanford Seed Spark competition
Startup | September 24, 2021

Health Sensei wins Stanford Seed Spark competition

Seed Spark is an online entrepreneurship program offered by Stanford Seed. Health Sensei emerged as a winner competing with 86 startups from their May-Aug 2021 graduating cohort


Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster
Drug Approval | September 23, 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups


Terumo India releases stamp to commemorate the centenary of Terumo Corporation
Events | September 22, 2021

Terumo India releases stamp to commemorate the centenary of Terumo Corporation

Terumo’s first product was the domestically produced, safe, high-quality thermometer. The company has since supported the healthcare ecosystem worldwide


SCHOTT expands tubing capacity in India
Packaging | September 22, 2021

SCHOTT expands tubing capacity in India

In India, almost all approved vaccines are packed in FIOLAX glass made by SCHOTT


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


Carmat announces first implant of its artificial heart in a woman
Healthcare | September 21, 2021

Carmat announces first implant of its artificial heart in a woman

The recipient is a 57-year-old woman who was suffering from severe biventricular heart failure and had undergone cardiac surgery several years ago


Imfinzi plus chemotherapy tripled patient survival at 3 years
Biotech | September 20, 2021

Imfinzi plus chemotherapy tripled patient survival at 3 years

The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting


Novartis’ Kisqali data indicates longest median survival in advanced breast cancer
Drug Approval | September 20, 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting