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Latest Biotech News

US drug approval comeback—Hepatitis D after prior FDA rejection

May 24, 2026

The FDA approved Gilead’s hepatitis D therapy Hepcludex (bulevirtide) roughly four years after the agency rejected the drug earlier, citing manufacturing and distribution concerns. The approval...

Oncology science—cholesterol transport enzymes as cancer vulnerability

May 24, 2026

Researchers at Sanford Burnham Prebys and collaborators at the University of Illinois Chicago reported in Science Advances that phosphoinositide kinases PI5P4Ks help regulate cholesterol...

CRISPR base editing—expanded-access case sets expectations

May 24, 2026

A University of Pennsylvania and Children’s Hospital of Philadelphia report that an mRNA-based CRISPR base editing therapy delivered to infant “Baby KJ” with CPS1 deficiency produced meaningful...

Biotech finance—Parabilis IPO following Regeneron deal

May 24, 2026

Parabilis filed for an initial public offering on the heels of a strategic research collaboration with Regeneron. The partnership spans up to $2.3 billion in potential payments and covers...

EU biotech funding—new growth fund to narrow capital gap

May 24, 2026

QEt’s proposed €5 billion cross-sector growth fund is positioned to address European biotech’s funding shortfall by creating another homegrown route for growth capital. The initiative is framed...

China clinical trials policy—new IIT rules and gray market effects

May 24, 2026

China’s new rules for investigator-initiated trials (IITs) are expected to tighten oversight while legitimizing pathways for modalities beyond cell and gene therapies, according to reporting on...

ASCO pre-meeting—cost-utility and perioperative readouts

May 24, 2026

Ahead of the 2026 ASCO Annual Meeting, organizers lifted the pre-meeting embargo on May 21 and highlighted multiple trial readouts across lung, gastrointestinal, and genitourinary cancers. The...

Company actions—Vizgen layoffs during restructuring

May 24, 2026

Vizgen laid off an unspecified number of employees as part of a strategic reorganization, according to company statements and employee reports. The spatial technology company said it is investing...

Regulatory approvals and pipeline milestones (oncology focus)

May 24, 2026

The FDA has approved datopotamab deruxtecan (Datroway; Dato-DXd) as a first-line option for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for...

Regulatory decisions on liver disease (hepatitis D)

May 24, 2026

Gilead won US approval for its hepatitis D drug Hepcludex (bulevirtide) after the FDA previously rejected the therapy roughly four years earlier. The agency cited manufacturing and distribution...

ASCO-adjacent oncology data flow and ADC competition

May 24, 2026

Ahead of ASCO 2026, abstract “snapshots” released by conference organizers are spotlighting oncology strategies that expand beyond KRAS in pancreatic cancer. Coverage also points to strong...

Big biotech finance: IPOs and cross-company collaborations

May 24, 2026

Parabilis filed for an initial public offering one day after signing a strategic collaboration with Regeneron that could reach up to $2.3 billion. The deal centers on “antibody-Helicon...

Capital gap and funding structures in Europe

May 24, 2026

Biocentury coverage points to Q’s proposed €5 billion cross-sector growth fund as a potential tool to narrow Europe’s biotech capital gap. The concept is aimed at increasing the availability of...

Clinical trial updates in immunotherapy and oncology mechanisms

May 24, 2026

New preclinical work indicates that targeting cholesterol transport enzymes could suppress tumor growth by starving cancer cells of needed lipid trafficking. Researchers reported that blocking...

AI in healthcare and connected diagnostics

May 24, 2026

Researchers described an interpretable machine-learning model intended for early detection of pediatric sepsis using routine lab inputs. By emphasizing explainability, the approach aims to make...

Regulated testing for high-consequence pathogens (Ebola diagnostics)

May 24, 2026

The WHO and CDC ramped up diagnostic testing for Bundibugyo Ebola as the outbreak in the DRC escalated in spread risk. WHO raised the threat level from High to Very High after assessing the...

Company actions and workforce restructuring

May 24, 2026

AbbVie announced a new round of 85 layoffs tied to its Irvine, California site within its eye-care business, effective July 20. The WARN notice continues a pattern of workforce adjustments at the...

Repositioning gene-editing evidence from expanded access to next-stage CRISPR governance

May 24, 2026

University of Pennsylvania investigators and clinicians discussed the Philadelphia “Baby KJ” CRISPR base-editing case study, characterizing it as a single-patient expanded access effort rather...

US regulatory approval: hepatitis D

May 24, 2026

FDA has granted approval to Gilead’s hepatitis D therapy Hepcludex (bulevirtide) after the agency previously rejected the drug over manufacturing and distribution issues. The decision reopens a...

US regulatory approval: triple-negative breast cancer ADC

May 24, 2026

FDA approved Daiichi Sankyo and AstraZeneca’s TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative breast cancer...