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FDA Rejects Capricor’s Duchenne Muscular Dystrophy Cell Therapy
Capricor Therapeutics received a Complete Response Letter from the FDA rejecting its Biologics License Application for deramiocel, a cell therapy targeting cardiomyopathy in Duchenne muscular...
Radiopharmaceutical Startups Attract Major Venture Funding
Innovative radiopharmaceutical developers are drawing significant investment, highlighted by Actithera’s $75 million Series A funding targeting fibroblast activation protein (FAP), and Nuclidium’s...
AI Advances in Protein Modeling and Drug Discovery
Microsoft Research unveiled BioEmu, a generative deep learning system capable of rapidly emulating protein equilibrium ensembles with high accuracy, accelerating protein dynamics research beyond...
FDA Approvals and Regulatory Developments in July 2025
The FDA began July strongly with multiple new molecular entity approvals, bringing the 2025 total to 19. Regulatory actions included approvals for Cochlear’s next-generation smart implant system...
Biomanufacturing Faces Looming Talent Shortage by 2028
Jason Beckwith, PhD, a biomanufacturing talent efficiency expert, warns of a potential 'talent singularity' by 2028 where demand for skilled biomanufacturing professionals will outstrip supply. He...
Cancer Detection and Monitoring Advances with New Technologies
Caris Life Sciences published pioneering data validating its platform for minimal residual disease detection and early cancer identification with commercial launches anticipated soon....
Biopharma Executive Changes and Industry Leadership Moves
Jazz Pharmaceuticals announced that current president and COO Renée Galá will succeed retiring CEO Bruce Cozadd on August 11. Separately, Bioptimus, QuidelOrtho, and Becton Dickinson made key...
Obesity Drug Market and Clinical Advances
Soleno Therapeutics reported stronger-than-expected sales growth for Vykat XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome, with net revenues between $31 million and...
Gut Microbiome’s Role in Vascular Aging Explored
Research led by cardiologist Jürg Beer at the University of Zürich highlights the impact of aging gut microbiomes on vascular senescence. Elevated microbial metabolites phenylacetic acid (PAA) and...
FDA’s Complete Response Letters Transparency: Impact and Limitations
The U.S. Food and Drug Administration has initiated a policy shift by publicly releasing over 200 complete response letters (CRLs) issued between 2020 and 2024 for drugs that were eventually...
Capricor’s Duchenne Muscular Dystrophy Therapy Faces Regulatory Setback
Capricor Therapeutics has received a complete response letter from the U.S. FDA rejecting its biologics license application for deramiocel, an allogeneic cardiosphere-derived cell therapy intended...
Biopharma Mergers and Acquisitions Surge With Merck's $10B Verona Purchase
Biopharma dealmaking reached a high point in June 2025, with total transaction value hitting $35.07 billion, marking the strongest month of the year. Among significant deals, Merck & Co. acquired...
Radiopharmaceutical Startups Secure Major Venture Funding
Radiopharmaceutical developers Actithera and Nuclidium have attracted significant venture capital investments to advance clinical and manufacturing capabilities. Actithera closed a $75.5 million...
Advances in AI for Protein Dynamics and Small-Molecule Function Prediction
New AI-based tools are accelerating drug discovery and protein research by modeling complex biological processes with enhanced speed and accuracy. Microsoft Research unveiled BioEmu, a generative...
Advances in Genomics and Cancer Detection Technologies
Emerging genomic and diagnostic technologies seek to improve early detection and monitoring of cancers. Personalis and Tempus AI expanded their collaboration to include colorectal cancer,...
Biomanufacturing Faces Looming Talent Shortage by 2028
The biomanufacturing industry is approaching a critical talent deficit projected around 2028, driven by growing demand for specialized skills outpacing supply. Jason Beckwith, PhD, of Merrill...
FDA Approvals and Regulatory Developments in July 2025
July 2025 has seen robust FDA approval activity with at least eight products awaiting decisions and multiple new drug entities (NMEs) approved in June, raising the 2025 tally to 19. Highlights...
Innovations in RNA and Allergy Therapeutics
Cutting-edge RNA and antibody therapies are emerging to address cardiovascular and allergic diseases. Shanghai Circode Biomed has advanced HM-2002, a circular RNA-based drug candidate for ischemic...
Leadership Changes Amid Biotech Industry Transitions
Jazz Pharmaceuticals appointed current COO Renée Galá as incoming CEO, succeeding co-founder Bruce Cozadd effective August 2025, signaling continuity amid operational shifts. Karyopharm...
FDA Publishes Drug Rejection Letters: A Push for Transparency
The FDA has publicly released an initial batch of over 200 Complete Response Letters (CRLs) from 2020 to 2024, marking a significant policy shift aimed at increasing transparency in drug approval...