Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioCryst’s HAE drug BCX7353 gets FDA fast track designation
The fast track designation gives BioCryst Pharmaceuticals the scope for frequent interactions with the FDA during development of the drug. It also gives the opportunity for priority review
The fast track designation gives BioCryst Pharmaceuticals the scope for frequent interactions with the FDA during development of the drug. It also gives the opportunity for priority review
Kapspargo Sprinkle, a U.S. Food and Drug Administration (FDA) approved, novel, patented formulation of metoprolol succinate, is the first and only extended-release sprinkle formulation of this beta1-selective adrenoreceptor
With this decision, eligible adults in the UK with hATTR amyloidosis can gain access to patisiran before the drug is granted marketing authorization by the European Commission (EC).
The phase 2 trial evaluated ridinilazole against Standard of Care vancomycin across 100 patients. By preserving the gut microbiome, the Summit drug was demonstrated to have brought down
The company’s announcement also included the issuance of $22m in shares upon conversion of debt into equity Participants included ARCH Venture Partners, the Wellcome Trust, Steven Paul M.D.,
The core component of the program will be to conduct a 24-week Phase 2 trial of the Company’s lead product candidate, GKT831, in patients with IPF. The academic
Included in the acquisition are branded topical prescription treatments for acne, fungal skin infections and rosacea, along with a variety of topical steroids, which had an annual turnover
ZIKV-IG was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in December 2017. Emergent BioSolutions senior vice president and antibody therapeutics business unit head
The approval is for the intravenous use of the Azedra injection in patients whose adrenal gland tumors are unresectable and have spread beyond the original tumor site and
Under the financial terms, Kite will provide research and development (R&D) funding for the collaboration and Gadeta will be eligible to receive future payments upon achievement of certain