Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 73

Results For "ANDA"

3105 News Found

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue
Drug Approval | February 14, 2026

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
News | February 13, 2026

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

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


Merck KGaA’s Belen Garijo to become CEO of Sanofi
People | February 13, 2026

Merck KGaA’s Belen Garijo to become CEO of Sanofi

Garijo will be the first woman to lead Sanofi in its history


Lupin Q3 FY26 consolidated PAT jumped 37.4% to Rs.  1,180.5 Cr
News | February 13, 2026

Lupin Q3 FY26 consolidated PAT jumped 37.4% to Rs. 1,180.5 Cr

U.S. market achieved record quarterly sales of Rs. 3,113.2 crore ($350 million), a 54% YoY increase, accounting for 44% of global sales


Hikal Q3 FY26: Revenue, EBITDA surge amid regulatory recovery
News | February 12, 2026

Hikal Q3 FY26: Revenue, EBITDA surge amid regulatory recovery

The pharmaceutical segment led growth, generating Rs. 337 crore in revenue, while the crop protection business contributed Rs. 157 crore


Apollo Hospitals reports robust Q3 earnings; profit after tax humps to Rs. 3,835 million
News | February 11, 2026

Apollo Hospitals reports robust Q3 earnings; profit after tax humps to Rs. 3,835 million

Revenue from operations rose to Rs. 23,637 million for the three months ended December 31, 2025


GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth
News | February 10, 2026

GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth

Launched in August 2025, GSK India’s Oncology business is rapidly gaining momentum


Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets
Drug Approval | February 07, 2026

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets