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NewsOryzon Gains Ema Cta For Vafidemstat Phase Ii Pms Study
Oryzon secures EMA CTA for HOPE-2, a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, where no approved pharmacologic treatment currently exists.
Inventiva Awaits Phase 3 Nativ3 Data For Lanifibranor
Eli Lilly Gains FDA Approval For Onswik Once-Weekly Insulin
Zenzi Pharma Gets Import Alert 66-79 After Ignoring FDA Requests
Merck Gains FDA Approval For Kidney Cancer Drug Combination
Latest news
11 storiesFDA Opens BsUFA Comments Ahead Of October 2026 Meeting
FDA schedules October 26 hybrid meeting on BsUFA reauthorization for FY2028–2032; public docket closes November 25, 2026.
Becton Dickinson Issues Class I Recall For Huons Kits
BD issues Class I correction for convenience kits containing Huons-manufactured sodium chloride ampules, flagging supplier qualification gaps for QA teams.
Ritedose Expands Capacity As Albuterol Shortage Ends
FDA resolves four-year albuterol shortage; Ritedose's expanded BFS capacity and four-strength portfolio now serve as standing domestic supply infrastructure.
Elicio Wins ESMO 2026 Oral Slot For Phase 2 Cancer Data
Elicio Therapeutics secures ESMO 2026 late-breaking oral slot for Phase 2 AMPLIFY-7P data, with Phase 3 manufacturing implications for CMC teams.
ADARx Wins $535M In IPO And AbbVie Private Placement
ADARx prices its upsized IPO at $17.00/share, raising $535M combined with AbbVie's concurrent 4.9% private placement stake.
Nuvectis’ NXP200 Wins Breakthrough Status In China
Nuvectis secures China CDE Breakthrough Therapy Designation for NXP200 while targeting a U.S. IND submission in Q4 2026, creating dual-track CMC and regulatory demands.
Kyverna’s Miv-Cel Shows 1-Year Data Ahead Of Q4 BLA
Kyverna's one-year KYSA-8 and KYSA-6 data support a Q4 2026 rolling BLA submission for miv-cel in SPS and gMG.
Pharma Now Debuts “Inside CDMO” Series With HIPRA's Managing Director Eduard Viladesau
Pharma Now's Inside CDMO: Behind the Glass debuts with HIPRA Biotech's Eduard Viladesau on leaving BCG to launch a CDMO and landing first client in 9 months.
Pharma Now Launches Global Conversation Series With CDMO Leaders to Decode the Industry's Next Chapter
Pharma Now launches Inside CDMO: Behind the Glass podcast series, engaging global CDMO leaders in candid conversations on industry trends and challenges.
Telix ITM Radiopharma Merger Agreement Announced
Telix combines with ITM to expand radioisotope manufacturing and its theranostic pipeline, creating a vertically integrated radiopharmaceutical company.
Bespak and Upperton Partner on Nasal Drug Development
Bespak partners with Upperton to integrate nasal device engineering with formulation and manufacturing expertise, accelerating CNS and nose-to-brain drug development.
Worth your time this week
CPHI Milan Pharma Awards 2026 Finalists Announced
Pharming Group Gains FDA Approval for Leniolisib in Children Aged 4–11 with APDS
Lonza Builds Oregon Spray-Drying Facility To Expand SDD Capacity
