Sorrento Nabs FDA Approval for Shingles Pain Patch That Could Hit Blockbuster Status
Sorrento Therapeutics, Inc. nabbed regulatory approval for ZTlido, a non-opioid pain treatment in the form of a super-sticky patch. Source: BioSpace
Portola Plunges After Hint of Delay for FDA Approval of Factor Xa-inhibitor
Shares of Portola Pharmaceuticals are falling after the company announced a delay of several months for possible regulatory approval of its Factor Xa-inhibitor antidote, AndexXa. Source: BioSpace
Finch Therapeutics Raises $36 Million Series B, Bringing Total to $77 Million
Finch Therapeutics closed on an oversubscribed Series B financing worth $36 million. Source: BioSpace
Rubius Therapeutics Raises $100 Million in Crossover Financing
Rubius Therapeutics has closed on an oversubscribed $100 million crossover financing. Source: BioSpace
Mylan Teams Up with Revance Therapeutics to Develop Botox Biosimilar
Mylan N.V. signed a global collaboration and license deal with Revance Therapeutics to develop and market a biosimilar to Botox. Source: BioSpace
Gelesis Secures $30 Million to Support Potential Approval of Weight Loss Drug
Boston-based Gelesis snagged $30 million to support potential manufacturing and commercialization of its anti-obesity drug. Source: BioSpace
U.S. Department of Justice to Take on Opioid Manufacturers and Distributors
With no end to the national opioid crisis in sight, the U.S. Department of Justice announced a plan to form a task force that will target opioid manufacturers and distributors.…
EMA Issues Revised Guidance on Biomarkers, Diagnostic Criteria for Alzheimer’s Medicines
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design…
FDA Issues Guidance on ICH Good Clinical Practices
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Source: Drug Industry Daily
FDA’s Office of Pharmaceutical Quality Releases First Annual Report
In its first ever annual report, the Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300…
- 1
- 2
- 3
- 4
- …
- 26
- Go to the next page