FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study

Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer

This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma

The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma

HanchorBio scores first FDA orphan drug tag for gastric cancer therapy

The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

FDA nod to Acrotech's new eczema treatment

ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis

Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components

Hikal Q3 FY26: Revenue, EBITDA surge amid regulatory recovery

The pharmaceutical segment led growth, generating Rs. 337 crore in revenue, while the crop protection business contributed Rs. 157 crore

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

Fitch upgrades Biocon Biologics outlook to positive, affirms ‘BB-’ rating