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news.Revive Therapeutics files pre-IND package to FDA for gout drug candidate REV-002
The submitted pre-IND package provides the US FDA with information on the company’s REV-002, as well as a clinical trial plan for a proposed US clinical trial. The
The submitted pre-IND package provides the US FDA with information on the company’s REV-002, as well as a clinical trial plan for a proposed US clinical trial. The
The final closing of the transaction is expected to take place on or before 07 July 2014. The acquisition is a significant milestone for GelStat and is expected
Recently, the US Adopted Names (USAN) Council has adopted necuparanib as the unique non-proprietary name for M402. Necuparanib, a heparan sulfate mimetic, is a novel oncology drug candidate
In the trial, AD04 showed clinical and biomarker effects consistent with disease modification in Alzheimer patients. Following treatment with AD04, effects consistent with disease modification were achieved for
European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at Toansa site that had led to the suspension of the GMP certificate
Currently, Isentress film-coated tablets are administered twice daily in accordance with the approved Prescribing Information. Isentress is an integrase inhibitor indicated in combination with other antiretroviral (ARV) agents
The solution is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. The company said that phenylephrine possesses predominantly
As part of the deal, arGEN-X will bring its entire suite of human antibody discovery technologies to a partnership focused on multiple targets aligned with Shire’s therapeutic focus.
The trial is designed to evaluate the long-term safety and efficacy of GCS-100 in patients who completed the initial 12-week Phase II study (GCS-100-CS-4002). In the 4003 extension
The product, which is available in the 5mg and 10mg strengths, is indicated for the treatment of narcolepsy and attention deficit disorder with hyperactivity. The company received final