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news.RedHill Biopharma to conduct ondansetron bioequivalence trial
The study protocol was reviewed and cleared by the FDA and Health Canada. RedHill has submitted an IND to the FDA and Clinical Trial Application (CTA) to Health
The study protocol was reviewed and cleared by the FDA and Health Canada. RedHill has submitted an IND to the FDA and Clinical Trial Application (CTA) to Health
The recall is announced due to post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots,
Gemcitabine is indicated for first-line therapy for ovarian, breast, lung, and pancreatic cancers. Uman is expected to file an abbreviated new drug application (ANDA) for gemcitabine with the
Meridian Medical Technologies, a Pfizer subsidiary, has signed a settlement agreement with Intelliject and Sanofi that will resolve pending patent litigation related to Intelliject’s NDA for its epinephrine
The EMR will provide an easy way to incorporate Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, psychiatric practice guideline-based clinical decision support and patient education material
It is prescribed under the brand name Oxsoralen-Ultra (methoxsalen) Capsules, USP, 10mg. Oxsoralen-Ultra, in combination with a special type of phototherapy called PUVA (Psoralen plus UVA light) therapy,
The agreement expands Evotec’s drug discovery platform into the area of respiratory diseases through IR Pharma’s expertise in in vitro and in vivo Respiratory pharmacology. Under the alliance,
The $20MM facility will serve to expand Asymchem’s capabilities in high volume processing and back-end ingredient and intermediate production. The new facility will accommodate high volume processes and
As per the terms of the agreement, Arno will pay certain research, clinical and regulatory milestone payments as well as royalties on net sales of licensed products to
AFC is contributing to the Rx-360’s joint audit pilot program as the first US-based active pharmaceutical ingredient (API) manufacturer to be audited. AMPAC quality and regulatory affairs vice