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Simultaneous advice from FDA and EMA? Very few companies go that route with new drugs, review finds
3 years ago
FDA+
Manufacturing roundup: GenSight terminates batch of gene therapy; Evonik opens lipid production site in Germany
3 years ago
Manufacturing
Apotex issues recall of eye treatment over cracked bottle caps
3 years ago
Pharma
FDA+
Sandoz to expand its presence in Slovenia with new $400M plant
3 years ago
Manufacturing
UMass medical school’s manufacturing unit lays off 26 employees
3 years ago
People
Manufacturing
AstraZeneca touts PhIII event-free survival win with Imfinzi
3 years ago
R&D
Coherus BioSciences lays off 20% of staff, while antimicrobial biotech makes deeper cuts
3 years ago
People
Neoleukin sends 70% of staff packing as IL-2 biotech searches for sale or other exit
3 years ago
People
Fresh Tracks considers options to stay afloat and develop autoimmune candidates
3 years ago
R&D
Flagship biotech 'Rings' in $85M+ for next-gen gene therapy effort
3 years ago
Financing
Cell/Gene Tx
Tagrisso reaches OS endpoint in PhIII EGFR-mutated lung cancer trial
3 years ago
R&D
Ten years later, Lilly's long-term Alzheimer's trial of solanezumab has definitively failed
3 years ago
R&D
Pharma
Short supply of commonly used cancer drugs raises concerns among hospital pharmacists
3 years ago
Pharma
Manufacturing
ALS biotech QurAlis gets $88M boost from four pharmas for pair of PhI studies
3 years ago
Financing
Startups
Industry advocates urge Senate health committee leaders to support antimicrobial pricing reform
3 years ago
Pharma
FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion
3 years ago
Pharma
FDA+
Organon doubles down on mission to prevent unplanned pregnancies with $30M investment
3 years ago
Pharma
Marketing
An eye, 15 seconds and striking animation: How Horizon's thyroid eye disease campaign hit home with patients
3 years ago
R&D
Novartis CEO takes pay cut as AbbVie's Rick Gonzalez nabs nearly 10% raise
3 years ago
Pharma
FDA inspection uncovers cherry-colored antibiotic residue on equipment at Teva's New Jersey site
3 years ago
FDA+
Manufacturing
FDA says no adcomm planned for Biogen, Sage's depression drug
3 years ago
FDA+
BioMarin seeks label expansion for achondroplasia drug; FDA lifts Inhibikase full clinical hold
3 years ago
News Briefing
Mesoblast’s aGVHD cell therapy will get another shot at the FDA
3 years ago
FDA+
Ex-NIH, Sanofi leaders nab Merck support for their biotech’s Epstein-Barr vaccine
3 years ago
Deals
Pharma
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