Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.
Read moreSanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.
Read moreA Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.
Read moreThe CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection
Read moreNeos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.
Read morePfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.
Read moreFDA today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
Read moreJapanese drugmaker Otsuka won FDA approval for a two-drug therapy for colorectal cancer, planning to market the combination as a treatment for advanced forms of the disease.
Read moreMerck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.
A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.
Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.
The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection
Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.
Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.
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