FDA & Biotech
8 minutes ago

Roche Gains FDA Nod for First-in-Class Lung Cancer Therapy

Tecentriq and Zepzelca combination approved as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC).

Read More
FDA & Biotech
2 hours ago

Novartis Gains FDA Approval for First-in-Class Oral Hives Drug Rhapsido

The approval of the twice-daily pill remibrutinib positions the company to challenge injectable treatments in a multi-billion dollar market.

Read More
FDA & Biotech
3 hours ago

Abivax Posts Positive Phase 3 Data for Ulcerative Colitis Drug

Late-breaking trial results for obefazimod show significant efficacy, positioning the first-in-class oral therapy in a competitive market.

Read More
FDA & Biotech
7 hours ago

FDA Greenlights New Lung Cancer Drug From Jazz and Roche

Combination therapy approval for small cell lung cancer offers a new standard of care and a bullish signal for the pharmaceutical sector.

Read More
FDA & Biotech
10 hours ago

Roche's Tecentriq Combo Wins Key FDA Nod for Lung Cancer

First-of-its-kind maintenance therapy approved for extensive-stage small cell lung cancer, a historically difficult-to-treat malignancy.

Read More
FDA & Biotech
13 hours ago

Alto Neuroscience Stock Jumps on FDA Fast Track for Schizophrenia Drug

The designation for ALTO-101 targets cognitive impairment, a debilitating aspect of schizophrenia with no currently approved treatments.

Read More
FDA & Biotech
17 hours ago

Corcept Shares Jump 5% as FDA Accepts Drug Application

The U.S. Food and Drug Administration has accepted for review the company's New Drug Application for Relacorilant, a treatment for Cushing's syndrome.

Read More
FDA & Biotech
20 hours ago

Biotech Sector Jumps on Trio of Favorable FDA Rulings

Key approvals for Regeneron, Corcept, and a Fast Track designation for Alto Neuroscience signal a positive regulatory environment.

Read More