Medtronic launches first 'intelligent' circular stapler to boost surgical precision, reduce leaks

The Signia Circular Stapler is the only circular stapler on the market with integrated leak testing and features designed to minimize risk

EU clears Bristol Myers Squibb’s CAR-T therapy Breyanzi for tough-to-treat Lymphoma

The European Commission’s green light marks Breyanzi’s fourth indication in Europe and extends access to patients across all EU and EEA countries

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy

Roche wins EU green light for one-minute injection cancer therapy

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia

Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval

FDA grants breakthrough status to Augurex’s SPINEstat test to advance early axSpA diagnosis

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable

Takeda and Innovent Biologics forge global partnership to advance oncology medicines for solid tumors

Takeda will make an upfront payment of $1.2 billion, which includes a $100 million equity investment in Innovent