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May 13, 2026
NewAmsterdam Pharma said regulatory decisions on obicetrapib in Europe, the UK and Switzerland remain expected in 2H26. PREVAIL interim analysis is planned for 4Q2026, with a result expected in 1Q2027.
May 12, 2026
A review in Genes & Diseases says robust non-clinical safety assessment is critical for CRISPR-based gene therapies. It highlights genotoxic, delivery, and immunological risks and recommends risk-based development programs.
May 08, 2026
PSMA-PET imaging leads to earlier use of advanced therapies like ARPIs in prostate cancer patients compared to bone scans. Real-world data on 177Lu-PSMA-617 shows comparable efficacy to the VISION trial in mCRPC patients.
May 06, 2026
The EU Critical Medicines Act enters trilogue negotiations as drug shortages persist. The Parliament proposes broader powers for a new coordination group, binding stockpiling, and expanded MEAT procurement criteria. EMA recorded 136 critical shortages from 2022-2024.
May 05, 2026
Cellectar Biosciences expanded its global IP estate and announced oversubscribed financing of up to $140 million. The funding supports iopofosine I 131 regulatory filings and a confirmatory study in Waldenström macroglobulinemia.
May 01, 2026
Ray Therapeutics received EMA PRIME designation for its RTx-015 optogenetic gene therapy for retinitis pigmentosa, following recent FDA RMAT status. The company also appointed Michael Murtagh as Chief Regulatory Officer to support global development.
Apr 30, 2026
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Apr 29, 2026
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Apr 24, 2026
The EMA’s CHMP recommended approval of Sanofi’s Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis. The phase 3 HERCULES study showed reduced disability progression, while liver injury remains an identified safety risk.
Apr 20, 2026
LENZ Therapeutics submitted a UK marketing authorization application for VIZZ for presbyopia on April 20, 2026. The filing follows FDA approval in July 2025 and EMA validation in March 2026.
Apr 14, 2026
The FDA has accepted Savara’s BLA for MOLBREEVI in autoimmune PAP and granted Priority Review with an action date of August 22, 2026. The application includes data showing improved pulmonary gas transfer, quality of life, and clinical symptoms.
Apr 13, 2026
PharmaMar and Globant deployed a multi-agent AI framework to accelerate oncology drug discovery. The system delivers over 90% accuracy in data retrieval and generates insights up to 15 times faster.
Apr 12, 2026
Iovance reported real-world data suggesting Amtagvi may have a best in class profile in advanced melanoma. The company posted $263.5 million in annual sales after 2024 approval, while pursuing broader use and facing regulatory and logistics risks.
Apr 11, 2026
Pharma robots and clean room pass-through systems are projected to grow through 2035 as drugmakers increase automation and contamination control. Demand is being driven by biologics, cell and gene therapies, stricter sterile-manufacturing requirements, and investment in cleanroom infrastructure.
Apr 01, 2026
Express Scripts has added Milestone Pharmaceuticals' CARDAMYST nasal spray to its national formularies, improving access to the first FDA-approved self-administered treatment for PSVT in 30 years. The drug was approved in December 2025 and clinical studies show it converts PSVT episodes twice as likely and three times faster than placebo. The company has also submitted a marketing application to European regulators.
Mar 31, 2026
The European Medicines Agency has approved Shield Therapeutics' FeRACCRU® for adolescents aged 12 and older, following FDA approval of ACCRUFeR® for children 10+. The expansion was supported by Phase 3 pediatric trial data showing efficacy and safety in children as young as 1 month.
Mar 31, 2026
The European Commission has approved KYGEVVI (doxecitine and doxribtimine) as the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra-rare mitochondrial disease. Clinical studies showed the drug reduces death risk by 95% and helps 84% of patients regain motor functions. The approval covers pediatric and adult patients with symptom onset before age 12.
Mar 30, 2026
Tempest Therapeutics reported 2025 financial results showing $7.7 million in cash and highlighted clinical progress including 100% complete response rate in TPST-2003 CAR-T trial and multiple FDA designations for amezalpat in hepatocellular carcinoma. The company completed strategic CAR-T asset acquisition and plans Phase 2b registrational study for its lead program in 2026.
Mar 26, 2026
The European Union has approved a higher 7.2 mg maintenance dose for Wegovy (semaglutide) for chronic weight management. Clinical trial data shows mean weight loss of 20-21% with the 7.2 mg dose compared to 17-18% with the standard 2.4 mg dose. The approval provides clinicians with an on-label option for patients with inadequate response to standard dosing.
Mar 25, 2026
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
