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FDA approval for first in vitro diagnostic for early Alzheimer’s detection

May 5, 2022
Business Services

The US FDA has approved the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD). …

News

BLINCYTO approved in China for leukaemia treatment

May 4, 2022
Research and Development

The China National Medical Products Administration (NMPA) has granted conditional approval of BLINCYTO (blinatumomab), as an injection for the treatment …

News

Amphista Therapeutics and Bristol Myers Squibb partner for development of protein degradation therapeutics

May 4, 2022
Research and Development

Amphista and Bristol-Myers Squibb have announced a strategic collaboration and license agreement.Under the terms of the collaboration, BMS and Amphista …

News

Smartphone app could screen for Alzheimer’s disease

May 4, 2022
Research and Development

Researchers at the University of California San Diego have developed a smartphone app with the potential to screen for Alzheimer’s …

News

WHO announce upcoming updates on treatment of drug-resistant tuberculosis

May 4, 2022
Research and Development

A rapid communication released by WHO Global Tuberculosis Programme has announced upcoming updates to the guidance on the treatment of …

News

Jyseleca recommended by HSE for treatment of ulcerative colitis in Ireland

May 3, 2022
Manufacturing and Production

Galapagos Biotech LTD has announced that further to approval from the Health Service Executive (HSE), eligible patients in Ireland will …

News

EU plans to cut unneeded medical tests with data health plan

May 3, 2022
Manufacturing and Production

The EC has announced plans to make health data easier to access for patients, medics, regulators, and researchers, to improve …

News

FDA approve first nonstimulant ADHD med for adults in two decades

May 3, 2022
Manufacturing and Production

The FDA has expanded the indication of Supernus’s Qelbree to patients aged 18 and older, marking the drug as the …

News

EC approves Cabotemyx as second-line treatment for thyroid cancer patients

May 3, 2022
Manufacturing and Production

The EC has approved the use of Cabotemyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally …

News

Discharging untested patients to care homes was ‘unlawful’, says high court ruling

April 29, 2022
Medical Communications

The High Court has ruled that government policies on discharging untested patients from hospital to care homes in England, at …

News

Pfizer DMD trial moves forward after FDA lifts hold

April 29, 2022
Medical Communications

Pfizer has announced that it will open the first ever US sites in its Phase III trial study, evaluating its …

News

FDA approval for first drug to treat inherited heart condition

April 29, 2022
Medical Communications

Bristol Myers Squibb has received approval from the FDA for their drug, Camzyos™ (mavacamten), marking the drug as the first …

News

OMass Therapeutics raises $100 million to progress immunology and rare diseases drug pipeline

April 28, 2022
Business Services

OMass Therapeutics have announced the $100 million (£75.5 million) Series B financing to progress its drug pipeline in immunology and …

News
fdaoutsideweb

NOCIRA announces breakthrough device designation by FDA for migraine treatment

April 28, 2022
Business Services

NOCIRA is the first company to announce the FDA’s Breakthrough Device designation for the treatment of migraine attacks in both …

News

Quell Therapeutics and Cellistic collaborate to develop T-regulatory cell therapy platform

April 27, 2022
Research and Development

Quell Therapeutics and Cellistic have entered into a strategic collaboration for the co-development of an iPSC-derived Treg cell therapy platform. …

News

Almost 200 cases of unexplained acute hepatitis in children

April 27, 2022

Around 190 unexplained cases of severe hepatitis have been found in children around the world, as scientists urgently investigate what …

News

Gesynta Pharma receives orphan drug designation by FDA for systemic sclerosis

April 27, 2022
Research and Development

Orexo has announced that their partner, Gesynta Pharma has been granted Orphan Drug Designation by the FDA, for OX-MPI (GS248), …

News

Enhertu granted FDA Breakthrough Therapy Designation

April 27, 2022
Research and Development

AstraZeneca’s Enhertu® (fam-trastuzumab deruxtecan-nxki) has been granted breakthrough therapy designation in the US for adult patients with HER2-low metastatic breast …

News

Beijing enforces mass COVID-19 testing and closes neighbourhoods

April 26, 2022
Medical Communications

Beijing is enforcing mass testing and closing down access to neighbourhoods as it seeks to contain a new COVID-19 outbreak. …

News

UK study finds raising frequency of COPD flare ups increases risk of death

April 26, 2022
Manufacturing and Production

The EXACOS UK study in Chronic Obstructive Pulmonary Disease (COPD), funded by AstraZeneca, has shown that an increasing frequency of …

News
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