The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company currently trading near its 52-week low of $0.66, announced it has received the first European regulatory approval ...

The global research agenda includes 33 research priorities for bacterial and fungal infections and 7 for drug-resistant ...

Emblaveo (aztreonam-avibactam) was approved for treating complicated intra-abdominal infections with limited or no treatment ...

CVM READ THE FULL CVM RESEARCH REPORT CEL-SCI Corporation (NYSE:CVM) reports fiscal year 2024 financial and operational ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.