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The approval is supported by strong preclinical data demonstrating MP1032's capacity to sustain muscle function.
The designation was based on the therapy’s novel mechanism and data showing its anti-tumour activity in B-cell malignancies.
The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults ...
The drug failed to meet its primary endpoints in clinical trials, but subgroup analyses hinted at modest benefits.
(RTTNews) - AB Science (ABSCF.PK) announced FDA and EMA authorization of a confirmatory Phase 3 trial of masitinib in metastatic castrate-resistant prostate cancer, using a harmonized protocol and ...
Drug regulators in the European Union (EU) are sticking to their recommendation to suspend the sale of dozens of generic drugs because of flawed clinical trials conducted in Hyderabad, India ...
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