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Thermo Scientific introduces the NanoDrop Eight UV-Vis spectrophotometer
Medical Device | September 23, 2021

Thermo Scientific introduces the NanoDrop Eight UV-Vis spectrophotometer

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


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


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


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

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


Technology to distinguish between bacterial and viral infections cleared
Medical Device | September 21, 2021

Technology to distinguish between bacterial and viral infections cleared

MeMed BV is a first-of-its-kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes


Glenmark receives ANDA approval for treatment of acne
Drug Approval | September 21, 2021

Glenmark receives ANDA approval for treatment of acne

Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

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


Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV
Biotech | September 18, 2021

Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV

Initiation of EBT-101 Phase 1/2 clinical trial expected later this year


U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations