The day in pharma, read in minutes.
NewsEvotec Partners With Plectonic to Advance T Cell Engager Platform
Evotec and Plectonic combine BiTco and LOGIBODY® platforms in a preclinical collaboration targeting T cell engager limitations in solid tumors.
Nicox Extends Cash Runway to Q1 2028 Ahead of NCX 470 PDUFA Date
India Glycols Spins Off Biopharma Unit as Ennature Bio Pharma
FDA CBER Convenes NGS Workshop on Biologics Detection Standards
aTyr Expects FDA Response on Phase 3 Sarcoidosis Study
Latest news
11 storiesTelix Completes BiPASS Enrollment, Secures FDA NDA Path
Telix completes 350-patient BiPASS enrollment and aligns with FDA on an NDA pathway for 68Ga-PSMA-PET in pre-biopsy prostate cancer imaging.
Elevar Presents CARES-310 Age Data at ILCA 2026
Elevar's CARES-310 post hoc data shows camrelizumab/rivoceranib mOS and mPFS gains over sorafenib across uHCC age subgroups at ILCA 2026.
Emcure Pharmaceuticals Appoints Anshuman Rai as VP
Emcure Pharmaceuticals names Anshuman Rai as Associate Vice President; portfolio and reporting line not yet disclosed.
CDT Equity Names Co-Founder James Bligh as CEO
CDT Equity names co-founder James Bligh as CEO as the firm consolidates its asset portfolio and separates executive oversight of its Sarborg investment.
FDA Warns Reliance Life Sciences Over Falsified Lab Records
FDA issued a warning letter to Reliance Life Sciences over falsified microbiology lab records and LIMS dilution-factor errors at its Navi Mumbai facility.
FDA Tightens DSCSA Portal Rules for Drug Traceability
FDA's DSCSA page reinforces traceability, portal, and 24-hour illegitimate product notification obligations for distributors and manufacturers.
FibroBiologics Secures U.S. Patent for Disc Disease Therapy
FibroBiologics secures U.S. Patent No. 12,716,055 for fibroblast conditioned media methods targeting degenerative disc disease, raising manufacturing and GMP questions for cell therapy CMOs.
Olympia Launches Gonadorelin Injection in 503B Portfolio
Olympia Pharmaceuticals adds a ready-to-use Gonadorelin 1 mg/mL injection to its 503B men's hormone catalog, now available across 49 states.
FDA Warns Peptide Partners Over Seven Unapproved Injectable Peptides
FDA's CDER issued a warning letter to Peptide Partners LLC for marketing seven unapproved injectable peptides, including semaglutide and tirzepatide, online.
FDA Issues Draft Guidance on AI Model Credibility
FDA's first draft guidance on AI model credibility for drug and biologics submissions introduces a risk-based, context-of-use framework for regulatory decision-making.
EMA Launches Pilot to Advance Non-Animal Testing Data
EMA opens a non-binding NAMs data submission pilot, giving pharma and CROs a structured route to regulatory dialogue on non-animal testing methods.
Worth your time this week
20260901124951.webp&w=1920&q=75&dpl=dpl_CE3VACNCZ5AoAf3CQ76nP9jikDry)
CDMO Live Americas 2026 brings the Biopharma Outsourcing Community
20260901130249.webp&w=1920&q=75&dpl=dpl_CE3VACNCZ5AoAf3CQ76nP9jikDry)
TMIV Imaging Launches AI-Driven CLARION CT in India
Evonik Invests C$150M to Triple Vancouver Pharma Capacity
