Page 62 - Human Use News Today

The European Commission has approved Novavax Inc's (NASDAQ: NVAX) Nuvaxovid (NVX-CoV2373), following a positive opinion for a full authorization from the Committee for Medicinal Products for Human Use of the 

Here, QA and compliance professionals can gain guidance on navigating regulation during development of drugs such as antibody therapeutics.

MediWound Ltd. (MDWD) said it has received positive scientific advice from the Committee for Medicinal Products for Human Use within the European Medicines Agency related to the development plan for the company's Phase III study of EscharEx in the treatment of Venous Leg Ulcers and to the overall data required for subsequent potential marketing authorization submission and commercialization.

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs...

A significant medical breakthrough is needed in the fight against metastatic breast cancer. According to the American Cancer Society, more than 3.1 million women in the United States have a history of invasive breast cancer. However, there’s hope ...

A pre-filled pen that will halve the number of tralokinumab injections for patients with atopic dermatitis receives a positive opinion from the European Medicine Agencys CHMP.

Merck had requested the regulator's Committee for Medicinal Products for Human Use (CHMP) to re-examine the application for molnupiravir, which is sold under the brand Lagevrio in several countries, after CHMP advised against its market authorization in February.The agency had said the drug could not demonstrate benefits in treating COVID patients who did not need oxygen support and were at the risk of their disease worsening. "We are evaluating our options on how we can generate addi...

Merck & Co Inc (NYSE: MRK) and Ridgeback Biotherapeutics have reportedly withdrawn their COVID-19 pill application in the European Union (EU).

(Alliance News) - AstraZeneca PLC on Monday said Soliris has been recommended for marketing authorisation in the EU for expanded use in generalised myasthenia gravis, gMG. The Cambridge-based pharmaceutical company said the treatment was recommended fo...

GSK announced two significant advancements on Monday, with the approval of an updated indication for Shingrix in Japan, as well as a positive opinion from the European Medicines Agency for daprodustat.