EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression

Suven Life Sciences announces positive topline results from Phase-2 PoC signal detection open label study of Ropanicant

The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD

Cupid targets Rs. 50 crore+ topline from B2C in FY 2024-25

Innovative product offerings to capitalise on emerging opportunities within and beyond the sexual wellness market

Vaishali Pharma Ltd recommends 1:1 bonus issue and 1:5 stock split

The company is making its mark through strategic initiatives, promising to become a significant presence in the evolving pharmaceutical sector

Ashland Rad-Sure indicators approved by AABB Standards-Compliant product program

Rad-Sure blood irradiation indicators are FDA 510 (k) cleared medical devices that offer positive visual verification of irradiation at the minimum specified dose

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile

ANVISA completes inspection at Caplin Steriles' facility at Gummidipoondi

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations