The day in pharma, read in minutes.
NewsPar Health Recalls 22 Lots of Argatroban Injection After Multi-Material Particulate Contamination Found
Par Health recalls 22 Argatroban Injection lots over multi-material particulate contamination, including stopper fragments and possible stainless steel.
FDA CBER Finalizes Compliance Policy on Blood Donation Suitability and Source Plasma Quarantine Hold Requirements
FDA Launches Rare Disease Framework Initiative Targeting Risk-Based CMC Review and Pre-Approval Inspection Reform
Hepion Pharmaceuticals Acquires Gravitas Life Sciences
FibroBiologics Secures Australian Patent Acceptance for Fibroblast-Based Spinal Disc Regeneration Method
Latest news
11 storiesFDA Issues Compliance Policy on Blood Pressure and Pulse Donor Eligibility for Blood Establishments
FDA's CBER issues compliance policy on donor blood pressure and pulse eligibility, with direct implications for Source Plasma collection and plasma-derived biologics supply chains.
Atara Biotherapeutics Gains FDA Acceptance of Tabelecleucel
FDA accepts Atara's tabelecleucel BLA resubmission as Class 2, setting a March 31, 2027 PDUFA date for the first potential U.S. allogeneic T-cell therapy approval.
ImmunityBio Gains FDA Expanded Approval for Anktiva in High-Grade Papillary BCG-Unresponsive NMIBC
FDA expands Anktiva's indication to high-grade papillary BCG-unresponsive NMIBC via efficacy extrapolation from CIS trial data.
Roche Signs $1.16 Billion Deal with Rona Therapeutics for Fat-Tissue Obesity Program
Roche's $1.16B Rona Therapeutics deal targets fat tissue directly, signaling manufacturing modalities beyond GLP-1 peptide infrastructure.
Sanner Group COO Frank Bamberg Appointed to Lead Operations
Sanner Group appoints Frank Bamberg as COO to grow pharmaceutical packaging and strengthen medical device CDMO manufacturing.
CERVAVAC WHO Prequalification Secured by Serum Institute
Serum Institute of India gets WHO prequalification for CERVAVAC, its quadrivalent HPV vaccine, enabling UN agency procurement.
BIX 2026 Counts Down to Opening with Post-GLP-1 Session on the Next Obesity Treatment Market
BIX 2026 unveils its conference schedule, featuring a Post-GLP-1 session on next-generation obesity treatments and market strategies.
Eurofins SF Analytical Laboratories FDA Warning Letter Issued
FDA cites Eurofins SF Analytical Labs for CGMP failures including unrecorded TNTC results and missing 0-CFU secondary verification at its Horsham, PA site.
Lovelace Biomedical FDA Warning Letter Cites GLP Data Failures
FDA issues Warning Letter to Lovelace Biomedical over QAU failures to reconcile raw data with final GLP study reports across two nonclinical protocols.
Hanlim Pharm FDA Warning Letter Cites Aseptic Failures
FDA cites Hanlim Pharm for aseptic technique failures and unidirectional airflow deficiencies at its South Korea sterile fill-finish site.
SCA Pharmaceuticals Receives FDA Warning Letter Over CGMP Gaps
FDA issues Warning Letter to SCA Pharmaceuticals over sterile compounding CGMP failures at its 503B outsourcing facility in Little Rock, Arkansas.
Worth your time this week
Bristol Myers Squibb’s RYZ101 Meets Phase 3 Endpoint in GEP-NETs
Phio Pharmaceuticals Completes PH-762 Commercial-Scale Batch
Lonza-Qurient Deal Expands Dual-Payload ADC Technology
