Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets

Bristol Myers Squibb receives USFDA accelerated approval of Krazati in combination with Cetuximab for CRC

Second FDA approval for KRAZATI - reinforcing its potential across tumor types

FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans

Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government

USFDA approves next-gen TKI Augtyro for treatment of solid tumors

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors

Farxiga approved in the US for the treatment of paediatric type-2 diabetes

Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date