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Results For "FDA"

1710 News Found

Zebra Medical Vision receives clearance for Coronary Artery Calcium (CAC) solution
Digitisation | September 28, 2021

Zebra Medical Vision receives clearance for Coronary Artery Calcium (CAC) solution

The CAC solution cleared by the U.S. FDA analyses already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with cardiovascular disease


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Tavneos (avacopan) approved for ANCA associated vasculitis in Japan
Drug Approval | September 28, 2021

Tavneos (avacopan) approved for ANCA associated vasculitis in Japan

It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan


Flex Films launches F-UHB-M film to replace aluminium foil
Packaging | September 27, 2021

Flex Films launches F-UHB-M film to replace aluminium foil

A high-value proposition recyclable film packed with industry-leading barrier and metal bond performance, sustainability quotient and U.S. FDA compliant


Zydus Cadila receives final approval for Apremilast
Drug Approval | September 24, 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy


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’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