Biotech

Roche To Start Phase 3 Study For Alzheimer's Prospect This Year After New Data From Phase 2

Arvinas Potential Parkinson's Treatment Shows Positive Data In Human Study

Johnson & Johnson's Tremfya Shows Efficacy In Late-Stage Psoriatic Arthritis Study

Arvinas Potential Parkinson's Treatment Shows Positive Data In Human Study

Johnson & Johnson's Tremfya Shows Efficacy In Late-Stage Psoriatic Arthritis Study

European Drug Regulator Approves AstraZeneca's Two Flagship Cancer Drugs For Breast And Lung Cancer Settings

Sangamo Therapeutics Stock Surges After The Bell: What's Going On?

European Drug Regulator Approves AstraZeneca's Two Flagship Cancer Drugs For Breast And Lung Cancer Settings

Sangamo Therapeutics Stock Surges After The Bell: What's Going On?

Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death

New Study Shows Shingles Vaccine Linked To 20% Lower Dementia Risk, GSK Stock Pops

Biotech Recent News

Vertex, Alnylam Best Positioned As Biopharma Braces For Tariff Impact, Goldman Sachs Flags Regeneron, Biogen Risks

Trump's new tariff move may raise U.S. pharma costs, with analysts warning of risks tied to EU manufacturing and shifting healthcare policies.

Trump Tariffs Spare Drugmakers But Threaten Diabetes Device Industry

Trump's 10% global tariff spares pharmaceuticals but impacts medical devices, with diabetes device makers facing the greatest strain. Large biopharma firms remain protected, while medtech companies navigate potential margin pressures and competitive shifts.

FDA Approves Amgen's Uplizna As First Drug For Chronic Immune-Mediated Fibroinflammatory Disorder

The FDA approved Amgen's Uplizna as the first treatment for IgG4-RD. The decision is backed by the MITIGATE trial, showing reduced flares and sustained efficacy.

Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst

Biotech stocks face a tough 2025 with SMid-cap losses up to 40% YTD. BofA cites FDA changes, tariffs, and capital struggles but notes potential opportunities.

FDA Delays Full Approval Decision On Novavax's COVID-19 Vaccine (UPDATED)

Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request more data beyond the April 1 deadline.

Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year

FDA grants accelerated approval to Novartis' Vanrafia for IgA nephropathy, with Phase 3 data in 2026 expected to support traditional approval.

Why Is French Pharma Giant Sanofi Stock Trading Higher On Thursday?

Sanofi's rilzabrutinib receives FDA orphan drug designation for two rare diseases. Clinical studies show meaningful response rates and reduced disease flares.

BeiGene Discontinues Lung Cancer Drug Study After Interim Data Showed Limited Survival Benefit

BeiGene ends its Phase 3 lung cancer trial for ociperlimab after a futility analysis. No new safety concerns were found, and study results will be shared later.

FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns

The FDA rejected Aldeyra's resubmission for reproxalap, citing efficacy concerns. The company plans another trial and aims to resubmit the NDA by mid-2025.

Biopharma: A 'Safe Haven' As Tariff Turmoil Rages On?

Biopharma is seen as a safe haven for investors due to its high-margin business model and flexibility in dealing with potential tariffs. Other key questions remain.

UK's Health Agency Endorses Pfizer's Blood Cancer Combo Therapy As First For Untreated Hodgkin Lymphoma Patients

NICE recommended Pfizer's Adcetris for NHS use in advanced Hodgkin lymphoma, citing strong trial data and a new discount agreement with Takeda.

Why Is Pharma Giant Roche Stock Trading Lower On Wednesday?

Roche's MUSETTE trial found no additional benefit of high-dose Ocrevus over the 600 mg IV dose, reaffirming its efficacy and safety for relapsing multiple sclerosis.

BioMarin Seeks Label Expansion For Palynziq After Positive Phase 3 Results In Adolescent Patients

BioMarin's Phase 3 trial shows Palynziq significantly reduces blood Phe in adolescents with PKU. The company plans a regulatory submission for label expansion.