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Regulatory News

In Pharma Industry Regulation section of PharmProm.Ru we cover latest Pharma News, Pharmaceutical Industry articles, Pharma Journals, Pharmaceutical articles and more.

Regulatory News

FDA partially suspends study of Curis’ lymphoma drug

Techno -
Curis, Inc., a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, April 11th announced that the U.S. Food...
Regulatory News

PRAC finds no causal link between Comirnaty and Spikevax mRNA COVID-19 vaccines and autoimmune hepatitis

Techno -
The April 4-7, 2022 Pharmacovigilance Risk Assessment Committee (PRAC) meeting noted no link between COVID vaccines and autoimmune hepatitis (AIH). The PRAC has concluded that...
Regulatory News

FDA Approves alpelisib as first and only treatment for PROS, a spectrum of rare conditions

Techno -
Novartis on Wednesday announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice® (alpelisib) for the treatment of adult and...
Regulatory News

Bioxcell Therapeutics announces FDA approval of IGALMI, the first new acute treatment for schizophrenia or bipolar disorder

Techno -
BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and immuno-oncology, on Wednesday announced...
Regulatory News

Biocon Biologics gets EMA’s backing for Inpremzia

Techno -
Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., announced today the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has...
Regulatory News

EU recommendations for seasonal influenza vaccine composition

Techno -
Every year, EMA's ad hoc Influenza Working Group issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by...
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