The day in pharma, read in minutes.
NewsAbbVie Files EMA Bid for Subcutaneous SKYRIZI in Crohn’s
AbbVie files with EMA for subcutaneous SKYRIZI induction in Crohn's, raising comparability and fill-finish questions for biologics manufacturers.
FDA Updates Withdrawn Product-Specific Guidance List
CDT Equity Validates AI-Driven Crystal Structures for Drugs
B. Braun Recalls Sodium Chloride Lots Over Zinc Oxide
Teva Bids $125M for BioXcel’s IGALMI in Bankruptcy Sale
Latest news
11 storiesCelularity Signs U.S. Deal with MuseCell for Dezawa Cells
Celularity's Florham Park cGMP site will manufacture Dezawa MuseCells and derived products for MCI, with $300M in projected purchases over five years.
FDA Warns Compounders on Glutathione After 30 Adverse Events
FDA links 30 adverse events to IV glutathione compounded from dietary supplement grade ingredient sourced from Medisca, citing endotoxin risk and supplier qualification failures.
FDA Extends Use Dates on Hospira, Baxter Vials Amid Shortages
FDA extends use dates on 14 injectable lots from Hospira and Baxter; no relabeling required, but disposal obligations apply when replacements arrive.
Sanofi Vaccines Wins FDA Nod for DAPTACEL DTaP Biologics License
FDA issues supplemental approval to Sanofi Vaccines Canada for DAPTACEL DTaP vaccine, marking continued post-approval change management activity under STN# 103666.
Priovant Wins a First FDA Nod for Brepocitinib in Dermatomyositis
Priovant's brepocitinib gains FDA approval as the first targeted therapy for dermatomyositis, backed by 52-week Phase 3 VALOR trial data.
Roivant Wins a First FDA Nod for Brepocitinib in Dermatomyositis
Roivant's LISRAYA (brepocitinib) gains FDA approval as the first targeted therapy for dermatomyositis, available immediately in the U.S.
Cronus Pharma Wins FDA Nod for Generic Robenacoxib Injection
Cronus Pharma secures FDA approval for a generic Robenacoxib injection, entering the veterinary NSAID injectable market under full GMP compliance requirements.
Propanc Reports Over 90% Tumor Inhibition for PRP
Propanc Biopharma reports >90% tumor growth inhibition and >2.5-fold survival benefit for PRP in preclinical PDAC models ahead of Phase 1b filing.
Verrica Completes COVE-2 Enrollment for YCANTH
Verrica completes COVE-2 enrollment; topline Phase 3 data for YCANTH common warts indication expected Q1 2027.
Abbott Wins CE Mark for Amulet 360 LAA Occluder
Abbott's Amulet 360 LAA Occluder gains CE Mark, backed by VERITAS Study data showing 99.8% implant success and 93.9% complete closure at 45 days.
Cormica Publishes FDA Compounding Enforcement Roadmap
Cormica TPM publishes a peer-reviewed analysis of FDA enforcement trends across 503A and 503B compounding facilities, mapping recurring inspection deficiencies.
Worth your time this week
Sanofi Gains Updated FDA Approval for TENIVAC Vaccine
Moleculin Hits Enrollment Milestone in Relapsed AML Trial
Nicox Secures April 2027 PDUFA Date for NCX 470 Glaucoma Drug NDA
