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Total 27 results found since Jan 2013.
MRI for all: Cheap portable scanners aim to revolutionize medical imaging
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The patient, a man in his 70s with a shock of silver hair, lies in the neuro intensive care unit (neuro ICU) at Yale New Haven Hospital. Looking at him, you’d never know that a few days earlier a tumor was removed from his pituitary gland. The operation didn’t leave a mark because, as is standard, surgeons reached the tumor through his nose. He chats cheerfully with a pair of research associates who have come to check his progress with a new and potentially revolutionary device they are testing.
The cylind...
Source: Science of Aging Knowledge Environment - February 23, 2023 Category: Geriatrics Source Type: research
Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems
The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance.This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing beyond the EUA period.Based on continuous analysis performed since the onset of the pandemic, all Roche molecular tests, including the cobas SARS-CoV-2 Qualitative test, detect all SARS-CoV-2 variants. Basel, 24 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted...
Source: Roche Investor Update - October 24, 2022 Category: Pharmaceuticals Source Type: news
U.S. FDA grants priority review to Roche ’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
If approved,Actemra/RoActemra would be the first U.S. FDA-approvedimmunomodulator for the treatment of COVID-19 inhospitalised patientsSince the beginning of the pandemic, more than one million peoplehospitalised with COVID-19 have been treated withActemra/RoActemra worldwide1Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European UnionRoche has established a comprehensive access approach to improve availability ofActemra/RoActemra around the worldBasel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has acce...
Source: Roche Investor Update - April 4, 2022 Category: Pharmaceuticals Source Type: news
Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern
Roche and its subsidiary,TibMolbiol, confirm that it has tests for research use that identify the SARS-CoV-2subvariants of concern, Omicron: BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and DeltaThe World Health Organization (WHO) has recently reported that the BA.2subvariant is steadily increasing in prevalence, specifically in Denmark Use of these tests assess the spread of circulating variants and can help monitor the potential impact of therapeutics, vaccines and public health interventionsAll Roche SARS-Cov-2 tests correctly identify the virus including these newsubvariantsBasel, 16 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)...
Source: Roche Investor Update - March 16, 2022 Category: Pharmaceuticals Source Type: news
Roche has rapidly developed additional testing options to differentiate mutations in the Omicron SARS-CoV-2 variant
Basel, 3 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and TIB Molbiol, a newly acquired subsidiary within the Roche Diagnostics division, have added three additional Research Use Only (RUO) test kits for the detection of mutations present in the novel B.1.1.529 Omicron SARS-CoV-2 variant: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). The World Health Organization (WHO) has classified the recently emerged SARS-CoV-2 variant, Omicron (B.1.1.529), as a COVID-19 variant of concern (VOC).The VirSNiP variant kits allow differentiation between unique mutation...
Source: Roche Investor Update - December 3, 2021 Category: Pharmaceuticals Source Type: news
mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry
“No!” The doctor snapped. “Look at me!”
I had been staring her in the eyes, as she had ordered, but when a doctor on my other side began jabbing me with a needle, I started to turn my head. “Don’t look at it,” the first doctor said. I obeyed.
This was in early August in New Orleans, where I had signed up to be a participant in the clinical trial for the Pfizer-BioNTech COVID-19 vaccine. It was a blind study, which meant I was not supposed to know whether I had gotten the placebo or the real vaccine. I asked the doctor if I would really been able to tell by looking at the syringe. &...
Source: TIME: Health - January 11, 2021 Category: Consumer Health News Authors: Walter Isaacson Tags: Uncategorized COVID-19 feature Magazine Source Type: news
European Union Greenlights BioNTech-Pfizer COVID-19 Vaccine After Agency Gives Safety Approval
(AMSTERDAM) — The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be used across the 27-nation bloc, raising hopes that countries can begin administering the first shots to their citizens shortly after Christmas.
The EU’s executive commission gave the green light just hours after the European Medicines Agency said the vaccine meets safety and quality standards. Brussels had been expected to take two or three days to endorse the market authorization move.
“As we have promised, this vaccine will be available for all EU countries at the same tim...
Source: TIME: Health - December 21, 2020 Category: Consumer Health News Authors: ALEKSANDAR FURTULA and FRANK JORDANS / AP Tags: Uncategorized COVID-19 wire Source Type: news
Moderna Requests Emergency FDA Authorization for COVID-19 Vaccine
Moderna is requesting emergency authorization from the Food and Drug Administration (FDA) for its COVID-19 vaccine on Monday — a development the company’s president tells TIME is an “incredible milestone.”
The filing for the company’s mRNA-based vaccine is the first step toward getting the shot into hospitals, pharmacies and health centers. The Massachusetts-based biotech is the second company, following Pfizer, to request authorization for a COVID-19 vaccine.
Unlike Pfizer’s shot, which is also based on mRNA, Moderna’s vaccine does not need to be stored at ultra cold temperatures ...
Source: TIME: Health - November 30, 2020 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 News overnight Source Type: news
Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Le...
Source: Roche Media News - November 24, 2020 Category: Pharmaceuticals Source Type: news
