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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 rejects Ampio’s proposed changes to a phase III study of a pain medication for osteoarthritis

Techno -
Ampio Pharmaceuticals, Inc., a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee...
Regulatory News

FDA postpones approval of Teva’s schizophrenia drug

Techno -
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell announced that the U.S. Food and Drug Administration (“FDA”) has issued a...
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...
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