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
The company does not expect the outcome of this inspection to impact its plans
The NanoDrop Eight simultaneously evaluates eight samples in 20 seconds or less and the instrument can also measure high-concentration samples of up to 200 absorbance units without dilution
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
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
MeMed BV is a first-of-its-kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
Initiation of EBT-101 Phase 1/2 clinical trial expected later this year
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
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