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

Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria

The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options

Dr Reddy’s enters hormone replacement therapy market with landmark brand acquisition

The acquisition marks the company’s strategic entry into the fast-growing Hormone Replacement Therapy (HRT) segment and significantly strengthens its gynaecology portfolio in India

Sanofi Healthcare expands Hyderabad Global Hub, boosts capacity to 4,500 staff

Backed by a multi-hundred-million-dollar investment, the expansion underscores Sanofi’s long-term commitment to India’s thriving life sciences ecosystem

Lilly’s Retevmo shows major survival boost in early-stage RET fusion lung cancer

The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease

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

Torrent Pharmaceuticals posts Rs. 577 Cr Q3 profit; nine-month earnings jump to Rs. 1,725 Cr

Akums surges in Q3 FY26 with 15% revenue jump, bags key EU & UK nods

Operational leverage kicked in during the quarter, with adjusted EBITDA rising 21% year-on-year to Rs 147 crore

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

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

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