Swadeshi Jagran Manch advocates for waiving animal trials in biosimilar approval process to make drugs more affordable and ...

The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.

CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission ...

As of June 30, 2025, Apellis had $370.0 million in cash and cash equivalents, compared to $411.3 million in cash and cash equivalents as of December 31, 2024. Apellis anticipates its cash, combined ...

These guidelines help ensure that products are fit for their intended use and comply with applicable regulatory standards.

The approval is supported by strong preclinical data demonstrating MP1032's capacity to sustain muscle function.

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases ...

CHMP has advised that Alhemo be approved for people with severe hemophilia A and moderate or severe hemophilia B without inhibitors.

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 ...