Jun 18, 2026
The FDA has accepted Gilead's New Drug Application for the investigational once-daily HIV regimen bictegravir/lenacapavir and granted priority review, with a PDUFA action date of August 27, 2026. The filing is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 data showing comparable efficacy in maintaining virological suppression. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment.
May 28, 2026
The Trump administration barred NIAID officials from WHO meetings, reclaimed $600M from four states, and faced a Senate report showing drug prices rising despite deals. New drugs average $353K a year.
Aug 05, 2026
Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
Aug 03, 2026
The 340B Drug Pricing Program faces scrutiny after a Florida fraud case and data showing hospitals earn billions in profits. Lawmakers propose new accountability measures, while hospital advocates defend its role in funding community care.
Jun 20, 2026
PancreaSure detected advanced PDAC with 87.9% sensitivity and 97.7% specificity, outperforming CA19-9 alone. PanMETAI, an AI metabolomics model, achieved AUC 0.99 in training and 0.93 in external validation for early PDAC detection.
Jul 30, 2026
The Trump administration’s proposed 2027 insurance regulation omits copay accumulator protections, allowing insurers and PBMs to continue diverting billions in manufacturer copay assistance from patients. Advocates warn that without action, rising out-of-pocket costs will further strain patients. The rule also fails to close a loophole for large group plans regarding essential health benefits.
Jul 28, 2026
Systematic review confirms hepatitis B birth dose is safe and effective; separate study finds childhood vaccination linked to significantly lower HBV coinfection in people with HIV.
Jul 23, 2026
Researchers have discovered a novel broadly neutralizing antibody, 007, that targets the HIV-1 V3 glycan site in a glycan-independent manner, overcoming escape mechanisms. The antibody demonstrated robust neutralization of resistant viral strains, synergized with existing antibodies in humanized mice, and is now advancing preclinically with Vir Biotechnology. This breakthrough may guide next-generation vaccine strategies amid ongoing efforts to induce broadly neutralizing antibodies through novel immunogen designs.
Jun 26, 2026
Studies reveal age-related infectious disease patterns including higher symptomatic rhinovirus risk in adults over 60, polypharmacy complications in infectious disease patients, and significant underutilization of COVID-19 antivirals among older adults despite proven benefits.
Jun 25, 2026
University of Alberta researchers have identified the protease GlpG as a new drug target for antibiotic-resistant E. coli, which causes hundreds of thousands of UTI deaths annually. Inhibiting GlpG prevented bacterial adhesion and biofilm formation in laboratory studies. The discovery addresses a global health emergency as antimicrobial resistance projections show it could cause cancer-level deaths by 2050.
Jun 16, 2026
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.
Jun 09, 2026
Maryland biotech leaders outlined a strategy to scale the state's life sciences ecosystem, focusing on community building, investor attraction, and federal alignment. Meanwhile, 18 states face limited access to HIV treatment assistance programs due to stagnant federal funding amid rising costs.
Jun 09, 2026
Biotech stocks Ocugen, Kodiak Sciences, and CytoDyn are experiencing market movements driven by clinical data and regulatory milestones, particularly Biologics License Application (BLA) filings. Ocugen saw a surge in short interest, Kodiak reached a 52-week high on positive trial results, and CytoDyn's stock remains volatile as it advances its monoclonal antibody pipeline.
Jun 08, 2026
Gilead Sciences reported Q1 2026 total product sales of $6.9 billion, up 5% year over year, with HIV revenue growing 10% to $5.0 billion. The company raised its full-year 2026 base business revenue guidance by $400 million to $29.4–$29.8 billion. Non-GAAP diluted EPS was $2.03, up 12%, while the company advanced its oncology and cell therapy pipeline.
May 14, 2026
South Africa will begin providing lenacapavir on June 5 after delays tied to postimportation testing, while Uganda has launched rollout of the twice-yearly HIV prevention injection in Lira.
May 12, 2026
Trump secured agreements with 16 pharmaceutical companies tied to TrumpRx.gov, including most-favoured-nation pricing and direct-to-patient discounts. Several companies disclosed price cuts for obesity, diabetes, insulin and other medicines.
May 09, 2026
Three advances in TB diagnostics: a portable $300 device delivering results in 30 minutes, a Quick DNA kit detecting drug resistance in 5 minutes, and an ultrasensitive test finding TB DNA in 12-16% of hospitalized US patients.
May 04, 2026
Pitt received $669.7 million in NIH funding in 2025 to rank No. 7 nationally. Penn Nursing received $17.9 million, ranking first among U.S. nursing schools.
May 01, 2026
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Apr 20, 2026
A cost-effectiveness analysis found home-based anal cancer screening increased participation versus clinic-based screening among sexual and gender minority individuals. The approach remained investigational because the FDA has not approved self-sampling for anal cancer screening.
