The day in pharma, read in minutes.
NewsLilly Achieves Oral GLP-1 Risk Reduction Data Signaling Solid Dosage Scale-Up Demand
Lilly's oral GLP-1 candidate shows strongest diabetes and CV risk reduction at 17.2 mg, raising solid dosage scale-up and CMO capacity questions.
TAPI Appoints Serge Rogasik as CEO to Drive Global API and CDMO Expansion
Roche Real-World Data Confirm Faricimab Durability Across Multiple Retinal Disease Indications
Roche Achieves Significant PFS Benefit with Giredestrant in Phase 3 ER+/HER2- Breast Cancer Trial
Teva Presents Ecopipam Phase 3 and OLE Data Supporting FDA Priority Review for Pediatric Tourette Syndrome
Latest news
11 storiesTeva Gains Journal Validation for Ecopipam's First-in-Class D1 Mechanism in Pediatric Tourette Syndrome
Teva's ecopipam D1 antagonist gains peer-reviewed support in pediatric Tourette syndrome, with Phase 3 data showing 50% relapse reduction.
FDA Hosts ICH M15 Webinar to Clarify Model-Informed Drug Development Submission Standards on October 29
FDA's October 29 webinar addresses ICH M15 MIDD documentation standards, offering regulatory teams direct access to FDA scientists before submission.
Bristol Myers Squibb Gains FDA Pediatric Approval for Camzyos in Obstructive Hypertrophic Cardiomyopathy
FDA expands Camzyos approval to adolescents aged 12–17 with oHCM, based on Phase 3 SCOUT-HCM trial data, triggering label and REMS review obligations.
Bespak Expands Nasal Drug Delivery Portfolio with NasaDose Ultra
Bespak launches NasaDose Ultra Soft Unit Dose Spray, combining its unit-dose platform with Resyca's soft-mist technology for sensitive and complex nasal therapies, including CNS.
Pharma Now's "Inside CDMO: Behind the Glass" Goes Inside Drug-Delivery Engineering with Phillips Medisize's Justin Westendorf
Pharma Now's Inside CDMO features Phillips Medisize's Justin Westendorf on drug-delivery engineering, human factors, and building usable, meaningful devices.
Adarx Closes A $602.5M IPO And Private Placement For SiRNA Runway
ADARx closes $602.5M IPO and AbbVie private placement, funding a broad siRNA pipeline across six therapeutic areas.
Greenwich Rx Recalls Glutathione Injections Over Endotoxin Levels
Greenwich Rx recalls ten glutathione injection lots over elevated endotoxin levels, with two adverse events reported following IV administration of a subcutaneous-only product.
FDA Launches C3TI Program To Accelerate Pragmatic Trial Workflows
FDA's C3TI Demonstration Program opens structured CDER engagement for sponsors integrating Bayesian, SSDC, or pragmatic trial designs under active INDs.
OGD Publishes Full Leadership And Divisional Structures For ANDAs
FDA's OGD publishes updated leadership and divisional structure, clarifying review authority for ANDA filers across bioequivalence, patent, and Orange Book functions.
FDA Outlines ARC Commitments And Orphan Drug Incentive Framework
FDA's CDER Rare Diseases Team details ARC Program structure and orphan drug incentives relevant to manufacturers in niche therapeutic markets.
Zealand Pharma Opens Cambridge Hub, Expands Biologics and Hybrid Modalities
Zealand Pharma opens its 53,600 RSF Cambridge hub, expanding from peptides into biologics and hybrid modalities under its Metabolic Frontier 2030 strategy.
Worth your time this week
EMA Advances New Pharmaceutical Legislation Implementation, Prioritising Antibiotic Vouchers and Regulatory Sandbox
EMA Sets 20 November 2026 Deadline for Type IA Variations to Secure Year-End Outcomes
Regeneron Achieves 73% Response Rate with Ubamatamab in Phase 1/2 LGSOC Trial
