FDA approves Novartis' Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer
The expanded approval establishes a potential new standard of care across metastatic prostate cancer stages.
Novartis · +7 outlets
AstraZeneca in talks with Bristol Myers Squibb on potential $400 billion megadeal
If completed, the merger would be one of the largest in pharmaceutical history, reshaping the industry landscape.
cnbc.com · +11 outlets
Experimental treatment significantly slows progression of fatal brain disease in women in clinical trial
The data mark a potential breakthrough for a condition with few treatment options, though the specific disease was not identified.
Medical Xpress · +14 outlets
FDA Advisory Committee backs Replimmune's RP1 for advanced melanoma
A positive panel vote increases the likelihood of FDA approval for this oncolytic viral therapy.
Cure Today
Novo Nordisk drug fails to reduce cardiovascular risk in late-stage trial
The setback raises questions about the broader cardiovascular benefit profile of Novo's pipeline beyond GLP-1 therapies.
ET Pharma · +14 outlets
Senate measure would block Trump plan to politicize federal research grants
A White House proposal to subject research grants to political scrutiny faces a temporary Senate roadblock, with implications for biotech funding.
STAT · +7 outlets
NTLA stock surges 35% ahead of first-ever Phase 3 readout for gene-editing therapy
Investors anticipate pivotal data for Intellia's gene-editing candidate, which could set a precedent for the CRISPR therapy field.
Stocktwits
FDA approves palbociclib for HR+, HER2+ breast cancer maintenance
The expanded indication offers a new maintenance option for patients with this aggressive breast cancer subtype.
The American Journal of Managed Care · +14 outlets
FDA approves novel ADHD drug; differs from existing treatments
A new mechanism-of-action ADHD therapy enters the market, potentially offering an alternative for patients who do not respond to stimulants.
AOL.com · +14 outlets
FDA Advisory Committee votes against recommending deramiocel approval
The negative vote casts doubt on the path to approval for this Duchenne muscular dystrophy candidate.
NeurologyLive · +14 outlets
FDA rejects Replimune's experimental melanoma drug; REPL stock falls 19%
The complete response letter for the oncolytic virus therapy disappointed investors and analysts.
Stocktwits · +1 outlets
AbbVie's Rinvoq wins EU approval as first systemic treatment for vitiligo
The approval opens a new indication for the JAK inhibitor in an autoimmune skin condition with limited systemic options.
indianpharmapost.com · +7 outlets
FDA fast-tracks psychedelic research after Trump executive order
The agency's move signals a shift in regulatory posture toward psychedelic-assisted therapies.
Stocktwits · +14 outlets
Michigan Supreme Court ruling allows probe into Eli Lilly insulin pricing
The court cleared the way for an investigation into allegations that Lilly charged excessive prices, leading to patient rationing.
STAT · +7 outlets
Moderna stock falls 5% after trimming financial outlook
The reduced guidance reflects weakening demand for COVID-19 vaccines and ongoing pipeline uncertainty.
TIKR.com · +2 outlets
Kelun-Biotech's TROP2 ADC sac-TMT advances toward first-line TNBC approval in China
The priority review status brings a promising antibody-drug conjugate closer to market for triple-negative breast cancer.
BioPharma APAC · +3 outlets
BioNTech's 16.8 billion euro question: why the market prices its cancer pipeline at zero
An analysis suggests investors are valuing BioNTech largely on its COVID franchise rather than its oncology pipeline.
AD HOC NEWS · +2 outlets
Merck deletes clinical trial hint; Legend Biotech CEO resigns
The weekly roundup captures regulatory and leadership changes across biotech, including FDA clearance of a novel ADHD drug.
londoninsider.co.uk