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CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
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CHMP recommends fenfluramine for LGS-associated seizures
Positive Phase III study data has prompted the CHMP to recommend FINTEPLA ®▼ (fenfluramine) for seizures associated with Lennox-Gastaut syndrome (LGS).
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Regulating heavy metals in cannabis: what can be learned from the pharmaceutical industry?
The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
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FDA approves nine generics for Lyrica drug
The FDA has announced that it has granted approval to the first nine generic drug applications for Pfizer’s Lyrica treatment.
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EMA releases medicinal approval recommendations
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
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Seizures could be stopped and prevented with implanted electronic device
Researchers have developed an electronic device which could help to detect, prevent and stop seizures from occurring in epileptic patients...
