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

USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals

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

USFDA approves expanded age indication for GSK’s RSV vaccine ‘Arexvy’

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes

USFDA inspection of Lupin’s Nagpur injectable facility with zero 483 observations

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).

Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA

This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death