Biotech financing runs on staged proof: seed capital buys discovery data, Series A buys a path to the clinic, and the gap between them kills more companies than any failed trial.
A generic copies a small-molecule drug exactly. A biosimilar only …
Molecular testing is moving to the point of care. Roche …
NIH's All of Us Research Program became the world's largest …
In vitro diagnostics are regulated as medical devices under different …
Orphan drug designation is a formal FDA status for drugs …
The FDA has issued a complete response letter for Alvotech's …
Vertex Pharmaceuticals has presented the first clinical data for Casgevy in children ages 5-11 at the American Society of Hematology annual meeting, on December 6, 2025, in Orlando. All evaluated…
Epigenetics is the field of study focused on changes in DNA that do not involve alterations to the underlying sequence, per NHGRI's Talking Glossary, which also calls the field epigenomics. The…
Medical device trials run on an Investigational Device Exemption, the instrument that "allows the investigational device to be used in a clinical study in order to collect safety and effectiveness…
AI-enabled medical imaging devices are regulated as medical devices whose software uses artificial intelligence, authorized through FDA's existing premarket pathways and tracked on the public…
A drug candidate reaches the clinic through an Investigational New Drug application, the exemption that lets a sponsor ship an unapproved drug to investigators. Per FDA, an IND is needed once a…
A bioinformatics pipeline is a chained, software-defined series of steps that converts raw sequencing output into analyzed results, recording every tool version and parameter used. It exists to solve…
Platform science in early-stage biotech is engineered, reusable biology — a delivery vector, an engineered binding domain, a data architecture — that one company claims can yield many programs rather…
The FDA has approved Shionogi's Xocova (ensitrelvir) as the first oral post-exposure prophylaxis for COVID-19 in adults and adolescents 12 years of age and older, the company announced on June 1,…
Eli Lilly said in May 2026 that it will invest an additional $4.5 billion at two of its three Lebanon, Indiana sites, lifting Indiana capital commitments above $21 billion over six years, per the…
Johnson & Johnson reported second-quarter 2026 sales of $25.31 billion, up 6.6% year over year, with Innovative Medicine sales of $16.384 billion, up 7.8% — per the earnings release filed with the SEC…
Lab automation in biotech has moved from liquid-handling convenience to process control: a nonlinear model predictive control system developed by Sartorius researchers increased continuous CHO…
PacBio (NASDAQ: PACB) announced on August 5, 2026 that SPRQ-Nx chemistry will raise per-run HiFi output on its Vega benchtop sequencer from 60 Gb to 90 Gb, per the company's press release. The U.S.…
GenScript Biotech Corporation and Tamarind Bio announced a strategic partnership on August 5, 2026, connecting Tamarind's AI-powered molecular design platform with GenScript's wet-lab validation…