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

World Pharma News

FDA grants Regenerative Medicine Advanced Therapy designation to Direct Biologics’ extracellular vesicle drug for Covid-19

Techno -
Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration has...
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...
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