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The resubmission, which provides information to specifically address the FDA-issued complete response letter received in September 2013, includes the results from an additional pharmacokinetic trial that was conducted

In January, Cipher acquired the Canadian commercialization rights to ozenoxacin from Ferrer, a Spanish pharmaceutical company. A total of 412 adult and paediatric patients aged two months and

Having secured the IND designation, the company now intends to start a multi-center, pivotal Phase II trial soon to evaluate JCAR015 in patients with r/r ALL. Registration of

The new drug product is a formulation of dactinomycin indicated to treat Ewing’s sarcoma, a rare type of childhood bone cancer. Orphan drug designation was awarded to the

In the European Union (EU), Humira is now the first and only medication approved for HS, a painful, chronic inflammatory skin disease, also referred to as ‘acne inversa’.

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Scientists at University of Kansas’ Higuchi Biosciences Center laboratories

The companies will jointly conduct and share the costs of a Phase Ib/II clinical trial seeking to determine whether the combination therapy can improve overall response rate, in

Healthcare providers will now have the option for either a gluteal or deltoid injection site for administering Abilify Maintena to patients with schizophrenia. Abilify Maintena is the first

Results from the study demonstrated that the trial did not meet its primary endpoint of non-inferiority in overall treatment response in isavuconazole-treated patients at the end of IV