Get the Daily Brief
Latest Biotech News
Regulatory milestone: oral PCSK9 expands cholesterol options
The FDA cleared Merck’s first oral PCSK9 cholesterol drug, Lipfendra (enlicitide), marking a major shift for patients who need deeper LDL lowering than statins alone. The once-daily pill reduces...
Big pharma moves into psychedelics for treatment-resistant depression
Eli Lilly agreed to acquire AtaiBeckley in a deal worth $2.8 billion upfront and up to $3.8 billion with development and regulatory milestones, pushing Lilly into psychedelic-based psychiatry....
Lung cancer partnership licensing deal lifts AstraZeneca’s EGFR franchise
AstraZeneca secured global rights to Dizal Pharmaceutical’s oral EGFR exon 20 insertion therapy Zegfrovy (sunvozertinib) in a licensing agreement valued at up to $1.5 billion. The structure...
Cell therapy manufacturing automation becomes a commercial scale focus
Autolomous and Cellular Origins announced end-to-end integration of their automation and digitization platforms to scale cell therapy manufacturing with standardized, traceable data flows across...
Radiopharmaceutical funding accelerates next phase of prostate cancer program
AdvanCell closed a $315 million Series D financing to advance its lead radiopharmaceutical candidate into late-stage development and expand US manufacturing capacity. The company said the funding...
Diagnostic scale-up: Qiagen bloodstream panel gains CE-IVD certification
Qiagen announced CE-IVD certification for its QiaStat-Dx BCID GN Plus AMR Panel, extending the company’s rapid molecular coverage for bloodstream infections. The panel is designed to detect 13...
Dx/tools M&A: Merck’s Bio-Techne, Thermo Fisher microbiology and Roche’s PathAI deals shape 2026 momentum
The life science tools and diagnostics sector logged a trio of billion-plus dollar transactions in the first half of 2026, highlighting consolidation across research, lab workflows and advanced...
Diagnostics revenue boost after Abbott’s Exact Sciences acquisition
Abbott reported second-quarter Diagnostics sales grew 42% to $3.09 billion, attributing the jump largely to its acquisition of Exact Sciences earlier in March. The company also disclosed higher...
New clinical-stage drug entering market: Celcuity’s Revtorpyk cleared by FDA
The FDA approved Celcuity’s Revtorpyk (gedatolisib) for a defined subset of HR-positive/HER2-negative advanced or metastatic breast cancer patients without a PIK3CA mutation, as a first commercial...
Policy and supply chain: US lawmakers push bill to map foreign drug manufacturing influence
A bipartisan Senate bill reintroduced by three senators would increase transparency around foreign influence in US drug supplies, starting with mapping foreign manufacturing in the pharmaceutical...
First-in-class oral PCSK9 inhibitor cleared in the US
The FDA approved Merck’s oral PCSK9 cholesterol drug, enlicitide (branded Lipfendra), marking the first US approval for an oral PCSK9 pill. The approval comes after clinical data showing LDL...
Big Pharma licensing expands lung cancer targeted therapy reach
AstraZeneca agreed to license Dizal Pharmaceutical’s oral EGFR exon 20 insertion therapy, Zegfrovy (sunvozertinib), in a deal potentially worth up to $1.5 billion. AstraZeneca will pay $600...
FDA nod for Celcuity’s PAM pathway inhibitor in HR+/HER2- breast cancer
The FDA approved Celcuity’s Revtorpyk (gedatolisib) in a subset of patients with HR-positive/HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, following...
Merck’s diagnostics surge after absorbing Exact Sciences
Abbott reported that Diagnostics sales jumped 42% in Q2 to $3.09 billion, driven largely by its March acquisition of Exact Sciences. The company said overall Q2 sales rose to $12.59 billion,...
FDA approval adds a new platform for cell therapy – allogeneic Treg-based product
FDA approvals in June included Tregzi (Orca-T), described as the first approved allogeneic Treg-based cell therapy. The product is designed as a precisely composed regulatory T-cell graft intended...
Large Series D funds radiopharmaceutical manufacturer for Pluvicto challenger
AdvanCell raised a $315 million Series D to advance a lead radiopharmaceutical candidate toward late-stage development and to expand US manufacturing capacity. The financing is framed as a...
Diagnostics scale-up strategy for tuberculosis drug-resistance testing in Africa
A TB diagnostics scale-up effort in sub-Saharan Africa is expanding targeted next-generation sequencing (tNGS) after an Eswatini pilot demonstrated high clinical impact. Researchers reported that...
UK prepares nationwide SMA newborn screening evaluation
England will evaluate whether to expand newborn screening to spinal muscular atrophy (SMA), starting lab testing of newborns in October. The evaluation is led by scientists at the University of...
CAR T delivery moves further into in vivo territory
Tempest Therapeutics detailed its in vivo CAR T pipeline built around CD7-targeted mRNA delivery using lipid nanoparticles (CD7-tLNP). The company is positioning the platform to broaden CAR T...
AI distribution pushes molecular diagnostics platform in India
French synthetic biology firm DNA Script signed a distribution pact for its Syntax enzymatic DNA synthesis instrument in India with Imperial Life Sciences (ILS). The deal covers sales, technical...