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Results For "U.S.-Food-and-Drug-Administration"

461 News Found

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


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


RenovoRx receives New 510(k) clearance from US FDA
News | September 08, 2021

RenovoRx receives New 510(k) clearance from US FDA

The company’s RenovoCath Delivery System designed for targeted treatment of solid tumours


Omeza Collegen Matrix gets U.S. FDA approval
Biotech | September 03, 2021

Omeza Collegen Matrix gets U.S. FDA approval

This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care


Janssen announces U.S. FDA approval of Invega Hafyera
Drug Approval | September 02, 2021

Janssen announces U.S. FDA approval of Invega Hafyera

Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months