The day in pharma, read in minutes.
NewsUnichem Appoints Pabitra Kumar Bhattacharya as MD and CEO
Unichem Laboratories names Pabitra Kumar Bhattacharya as MD and CEO in a leadership shift worth monitoring for compliance and supply chain.
Olympia Launches Polidocanol Injection Across 49 States
FDA MedWatch Framework Flags Thyroid Tablet Recall Amid Potency Concerns
FDA Approves Zanidatamab and Tislelizumab for HER2-Positive GI Cancers
FDA Finds Undeclared Dexamethasone in Pain-Relief Product
Latest news
11 storiesREGENXBIO Faces Second FDA Clinical Hold on RGX-121
FDA issues second 2026 clinical hold on REGENXBIO's RGX-121 after spine MRI findings in five CAMPSIITE participants; BLA resubmission delayed indefinitely.
Janssen Wins FDA Approval for Nipocalimab as First Warm AIHA Drug
Janssen's Imaavy becomes the first FDA-approved treatment for wAIHA, setting a new regulatory and manufacturing benchmark for IV orphan biologics.
FDA Schedules Bayesian Guidance Webinar For Regulatory Teams
FDA's October 14 CDER webinar unpacks the January 2026 Bayesian methodology draft guidance, with direct implications for pediatric and rare disease trial submissions.
FDA Updates DSCSA Waiver Framework With Small Business Exemption
FDA's August 2026 DSCSA exemption for small business dispensers updates the waiver framework manufacturers and trading partners must navigate for Section 582 compliance.
FDA Reinforces Multi-Layer Drug Supply Chain Security Framework
FDA reaffirms DSCSA-based supply chain security, with 24-hour illegitimate product reporting and import controls as core compliance requirements.
Vitruvias Recalls Thyroid Tablets 30 mg Lot Over Superpotency
Vitruvias Therapeutics recalls Thyroid Tablets USP 30 mg Lot 504950 after testing confirms superpotency, with 1,955 units sold nationwide.
Capricor's Deramiocel Gets November 2026 FDA Review Date
FDA extends deramiocel PDUFA date to November 22, 2026, after accepting HOPE-3 open-label extension data as a major BLA amendment.
FDA Advances eCTD 4.0 and ESG Cloud Modernization Under PDUFA VII
FDA's PDUFA VII IT roadmap advances eCTD 4.0 and ESG cloud modernization, setting defined timelines for regulatory submission workflow changes.
FDA Sets RDEA Meeting Requirements for Rare Disease Endpoints
FDA's RDEA Pilot Program now requires complete, structured meeting packages before scheduling, incomplete submissions are returned with a deficiency list.
FDA Updates Ozempic Counterfeit Warning Amid GLP-1 Risks
FDA's third counterfeit Ozempic advisory signals persistent GLP-1 supply chain vulnerabilities, raising DSCSA compliance urgency for manufacturers and distributors.
Bristol Myers Squibb Signs AI Deal With Chai To Accelerate Drug Discovery
BMS partners with Chai Discovery to apply AI to antibody discovery, compressing timelines with implications for CMC and regulatory documentation.
Worth your time this week
FibroBiologics Appoints Leigh Steinberg as Board Director to Advance Longevity Pipeline
Lexicon Secures Third $10M Milestone from Novo Nordisk for Phase 1 Dosing
SciSparc-Clearmind Collaboration Wins U.S. MDMA-PEA Patent
