Topic: complete response letter
Merck canceled its partnership with Samsung Bioepis for a Lantus biosimilar after facing hurdles with pricing and production costs.
GSK's Nucala took a big hit Friday when the FDA stiff-armed its hoped-for new approval in COPD, which could have boosted sales significantly.
ADMA Biologics has its ducks in order to move forward with specialized plasma products that were sidelined by manufacturing issues.
Evolus, which had its Botox rival sidelined by the FDA in May, believes it has its manufacturing figured out and says it is back on track.
Allergan aims to sell its women’s health unit, but Esmya's FDA rejection will take a big bite out of its price.
Only days after the FDA turned away Regeneron's Eylea for a label expansion, the drugmaker has secured the approval it sought.
The FDA has issued a CRL for Regeneron's application to extend the dosing schedule for blockbuster Eylea from eight to 12 weeks.
Portola has hired a 30-year pharma veteran to oversee its manufacturing after running into production delays for its blood thinner antidote.
Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.
Thought Mylan might snag a generic Advair approval on its second try? Think again.