News

Teduglutide, which is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), gained orphan drug designation for the treatment of SBS from the EMA and FDA. Takeda

The marketing authorization is valid in the current European Union Member States as well as in Iceland and Norway. AMAG president and chief executive officer William Heiden said

StartingPoint, with an expanded range of content templates and new capabilities supporting document creation and validation, provides predefined heading styles, fonts, margins and table formats to ensure a

Teva filed lawsuit against Momenta/Sandoz and Mylan/Natco for infringement of multiple patents covering the chemical composition of Copaxone, methods of using the product and processes for manufacturing the

The FDA has completed the review of the company’s investigational new drug application for Kevetrin. The Phase 1 trials were scheduled to be conducted at Harvard Cancer Center’s

The Phase III double-blind study randomised 808 people with HER2-positive mBC, which recurred after prior therapy in the adjuvant or neoadjuvant setting. Genentech global product development head and

According to NTP, the requirement for an informatics system, to manage the chemistry and related data, made the company assess and evaluate available solutions in the market. The

Data from three of the Novartis Phase III GLOW trials, which included 1,996 COPD patients, announced the CHMP’s positive opinion for Seebri Breezhaler . Seebri Breezhaler was well

The study showed that GKT137831 is safe and well tolerated following oral administration of single doses in 36 healthy subjects. Pharmacokinetic analysis demonstrates good dose proportional exposure to