The answer is that Pharming was granted the PRV by the FDA after it claimed approval for Joenja (leniolisib), a therapy for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare and ...

The U.S. Food and Drug Administration has approved Genentech's Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular ...

The ranibizumab injection could be administered in a convenient schedule twice per year for the treatment of diabetic macular ...

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...

The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...

Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in positive trial results that could set it up for a full approval.

The US Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh) as a biosimilar of the original reference biologic tocilizumab (Actemra), according to a January 30 announcement ...

Ozempic Approval Expanded to Include T2D Patients ... patients as young as 1 year old experiencing fat malabsorption. FDA Clears Digestive Enzyme Cartridge RELiZORB for Kids as Young as 1 Year ...

Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...

The U.S. Food and Drug Administration approved a new prescription-strength pain reliever from Vertex Pharmaceuticals on Jan. 30, 2025. Journavx is a non-opioid drug that prevents peripheral nerves ...

Onapgo, a subcutaneous apomorphine infusion device, is approved for advanced Parkinson's disease, offering continuous symptom management without surgery. The TOLEDO trial showed apomorphine ...

Novo Nordisk said on Wednesday it plan to file its experimental next-generation obesity drug CagriSema for regulatory ...