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Hepion Pharmaceuticals Gains FDA Clarity on GV104 Pathway for Gambling Disorder
FDA confirms Hepion's GV104 can cross-reference existing IND data for gambling disorder under a 505(b)(2) pathway, with Phase 2 design accepted as appropriate.
FDA Pediatric Advisory Committee Releases September 2026 Meeting Materials for Biologics Review
Dogwood Therapeutics Secures $5 Million from CK Life Sciences to Fund Halneuron Phase 3 Preparation
Cormica Develops Dual-Detection HPLC Method for Potent API Classification
Insmed Launches BRINSUPRI in Japan for NCFB Treatment
Latest news
11 storiesAbbVie’s ABBV-466 Achieves 40.5% Endoscopic Remission in Crohn’s Trial
AbbVie's ABBV-466 outperforms anti-IL-23 and anti-α4β7 monotherapy in Phase 2a Crohn's data, raising manufacturing complexity for biologics CMOs.
Thermo Fisher CPHI Milan 2026: Drug Development Expansion
Thermo Fisher expands drug development, sterile and biologics manufacturing and clinical supply capabilities at CPHI Milan 2026.
Telix and Ekalia Sign Collaboration to Scale Astatine-211 Production
Telix and Ekalia formalize a U.S. astatine-211 production collaboration, installing the first IBA alpha-beam cyclotron at RLS Trevose near Philadelphia.
Alembic Pharma Wins FDA Approval for Generic Ciprodex Ear Drops
Alembic Pharma wins FDA ANDA approval for generic Ciprodex Otic Suspension, expanding its U.S. specialty suspension portfolio.
Viatris Wins FDA Approval for RYZUMVI to Treat Presbyopia
Viatris secures FDA approval to expand RYZUMVI into presbyopia, adding a second indication to the phentolamine ophthalmic solution via an Opus Genetics license.
Analytik Jena Opens €96M German Facilities to Expand Lab Capacity
Analytik Jena opens €96M German facilities, expanding lab instrumentation output that could ease procurement pressure for pharma QC labs.
FDA Creates CDER Exclusivity Board to Standardize Drug Rulings
CDER's new Exclusivity Board will oversee NCE, new clinical trial, and biologic exclusivity determinations to improve consistency across rulings.
Alcon Wins FDA Approval for Brytly Nonprescription Eye Drops
Alcon's Brytly becomes the first nonprescription apraclonidine eye drop approved by FDA, signaling continued agency push on OTC drug access.
FDA Warns of Bacterial Contamination in Counterfeit Eye Drops
FDA confirms bacterial contamination in counterfeit eye drops from DLC Laboratories, ProMex, and Laboratorios Sophia found across six U.S. states.
EMA CHMP Recommends Six Medicines for Approval in October 2026
EMA's CHMP issued six positive opinions in October 2026, including oral GLP-1 orforglipron and two biosimilars, with key implications for EU market entry.
Adial Appoints David Rubenstein as Chief Scientist for AT177
Adial Pharmaceuticals names tapinarof architect David Rubenstein as Chief Scientist to lead AT177 through IND-enabling studies toward 2027 first-in-human trials.
Worth your time this week
Dermata Reports Positive Results from Tome Skincare Study
Oryzon Secures Vafidemstat Patent Allowances in Four Markets
Zealand Pharma Partners With Generate on $1.2B AI Obesity Deal
