The approval is based on the benefit observed with the Perjeta regimen in achieving pathological complete response (pCR) in the neoadjuvant treatment of HER2-positive early breast cancer (eBC).
The trial evaluated the efficacy and safety of two different plecanatide treatment doses (3mg and 6mg), taken as a tablet once-a-day, in 1337 adults with CIC. According to
The one-year open-label, multi-center, single arm ADRESU trial is designed to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment
The FDA approval is based on results from two pivotal clinical trials evaluating the efficacy and safety of Finacea Foam compared to the foam vehicle in the topical
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
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