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A joint FDA advisory committee voted in favor of the safety, efficacy and risk-benefit profile of Janssen’s NDA for treatment of treatment-resistant depression. Read More
A new EU safety net for snaring illicit drugs went into effect on Feb. 9 — but the UK may not be under its protection for very long, according to the Association of the British Pharmaceutical Industry (ABPI). Read More
In a first-of-its-kind action, the Department of Justice filed suit against two Tennessee pharmacies to prevent them from dispensing opioids. Read More
Pfizer asked the FDA to clarify the term “total content” in its draft guidance for biosimilar development, for demonstrating that a drug and a reference product have the same strength. Read More
Australia’s Therapeutic Goods Administration (TGA) is asking for feedback on changes it’s considering for its generic drug market authorization process — including the potential use of foreign reference products to show bioequivalence. Read More