Molecular testing is moving to the point of care. Roche said on December 2, 2025 that its cobas liat Bordetella test received FDA 510(k) clearance and a CLIA waiver, with results in about 15 minutes, per the company. On August 6, 2026, Co-Diagnostics announced a dual 510(k) with a concurrent…
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 …
Lab automation in biotech has moved from liquid-handling convenience to …
The FDA has issued a complete response letter for Alvotech's …
Moderna has dosed the first patient in a Phase 1/2 …
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 children in the sickle cell cohort remained free of vaso-occlusive crises for up to two years after…
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 commercial and scientific interest sits in the platforms that read those changes at scale: sequencing-…
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 data," per FDA — and all such evaluations, unless exempt, "must have an approved IDE before the…
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 AI-Enabled Medical Device List. The list exists, per FDA, to identify AI-enabled devices authorized for…
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 sponsor that has screened a molecule for "pharmacological activity and acute toxicity potential in…
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 reproducibility: as the Nextflow authors wrote in Nature Biotechnology, the main source of…
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 than one. The claim is cheap; the validation is not. It arrives as published methods, reference…
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, 2026. The approval, covering use after contact with an individual who has COVID-19, came ahead of…
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 company's announcement. A December 2025 decision to spend more than $6 billion on an Alabama API…
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 on July 15, 2026. The company raised full-year guidance to reported sales of $101.1 billion and…
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. list price per run drops from $1,100 to $995. A software update adds two-hour and four-hour run…
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 services. The companies describe the arrangement as a connected validation engine for AI-enabled…
US bioeconomy policy in September 2026 still has no replacement for Executive Order 14081, the September 2022 directive that organized federal biotechnology strategy, eighteen months after its revocation on March 14, 2025. The operative instruments are legacy programs and a 2025…