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Results For "Food-and-Drug-Administration"

1255 News Found

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


US FDA grants Emergency Use Authorisation for Covid-19 pooled samples
Biotech | September 14, 2021

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples

Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test


US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Drug Approval | September 12, 2021

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma


US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction


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