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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 restricts J&J’s COVID-19 vaccine on blood clot risks

Techno -
The Food and Drug Administration is limiting the use of the J&J shot, which received U.S. clearance in February 2021. In a statement released on...
Regulatory News

FDA refuses to approve China-tested cancer drugs, shares fall

Techno -
The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, raising concerns over the future of drugs tested in...
Regulatory News

FDA approves Sol-Gel’s drug for treatment of inflammatory lesions of rosacea

Techno -
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), announced the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY®, a proprietary cream formulation of benzoyl...
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...
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