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 …

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 …

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, Camzyosâ„¢ (mavacamten), marking the drug as the first …

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 …

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 …

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. …

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 …

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), …

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 …

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. …

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 …

FDA approves first COVID-19 treatment for young children

April 26, 2022
Manufacturing and Production

The FDA has expanded the approval of the COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age …

Mundipharma and Cidara Therapeutics report positive Phase III results into candidemia treatment

April 26, 2022
Medical Communications

Mundipharma and Cidara Therapeutics have presented data from the Phase III ReSTORE trial of rezafungin, in the treatment of candidemia …

New data for Shionogi’s COVID-19 antiviral show rapid virus clearance

April 25, 2022
Sales and Marketing

Shionogi has announced new results from two late-breaking presentations of S-217622. This is an investigational 3CL protease inhibitor that was …

National shortage of HRT medication due to high demand

April 25, 2022
Sales and Marketing

The national shortage of HRT products could have an impact on some women, who may not be able to sleep …

EMA recommend new treatment option for severe postpartum haemorrhage

April 25, 2022
Sales and Marketing

Novo Nordisk has announced that the EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion …

Ukraine: crisis for people with chronic diseases

April 25, 2022
Sales and Marketing

Preliminary results from an ongoing nationwide health needs assessment, conducted by WHO in partnership with Premise, indicate that one in …

Vivesto signs agreement with CRO to evaluate anti-cancer drug formulations

April 22, 2022
Medical Communications

Vivesto AB, an oncology-focused pharmaceutical company, has announced that it is advancing research into its proprietary drug delivery formulations, and …

Orasis Pharmaceuticals announces positive Phase III results of eye drop candidate

April 22, 2022
Medical Communications

Orasis Pharmaceuticals has announced that the Phase III NEAR-1 and NEAR-2 clinical trials, which evaluated the efficacy and safety of …

FDA approves Phase III Acute Respiratory Distress Syndrome (ARDS) Trial

April 22, 2022
Medical Communications

The FDA has approved Direct Biologics to proceed with its Phase III clinical trial into the treatment of Acute Respiratory …

The Gateway to Local Adoption Series

Latest content