Lupin receives US FDA nod for Nagpur injectable facility manufacturing drug-device combinations

Pallavi Madhiraju- April 20, 2025 0

Lupin secures US FDA EIR for its Nagpur injectables facility, boosting export potential and complex generics expansion. Read how this impacts global strategy. Read More

Gland Pharma wins key FDA nod for $55m painkiller drug, but stock slips after initial surge

Pallavi Madhiraju- April 6, 2025 0

Gland Pharma secures US FDA approval for Acetaminophen Injection as its stock sees volatility. Find out what this means for investors and market strategy. Read More

Senores Pharmaceuticals expands US footprint with Roflumilast ANDA acquisition

Pallavi Madhiraju- February 21, 2025 0

Senores Pharmaceuticals Limited has taken a significant step in its US expansion strategy by acquiring an Abbreviated New Drug Application (ANDA) for Roflumilast 250 mcg ... Read More

Lupin shocks the market with massive profit gains in Q3 FY2025—here’s what you need to know

Pallavi Madhiraju- February 12, 2025 0

Lupin Limited, a leading global pharmaceutical company, has reported strong financial results for the third quarter of fiscal year 2025, reflecting its strategic focus on ... Read More

FDA authorizes Virtual Incision’s MIRA: A leap forward in robotic-assisted surgery

Pallavi Madhiraju- February 25, 2024 0

Virtual Incision Corporation has achieved a groundbreaking milestone with the U.S. Food and Drug Administration (FDA) granting marketing authorization for the MIRA Surgical System (MIRA), ... Read More

FDA approves biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals

Pallavi Madhiraju- February 25, 2024 0

Alvotech and Teva Pharmaceuticals have achieved a significant milestone with the U.S. Food and Drug Administration's (FDA) approval of SIMLANDI (adalimumab-ryvk) injection. This approval positions ... Read More

Orchid Pharma bags FDA approval for Enmetazobactam, first Indian-invented beta lactamase inhibitor

Pallavi Madhiraju- February 24, 2024 0

Chennai-based Orchid Pharma has achieved a significant milestone by receiving approval from the United States Food and Drug Administration (USFDA) for Enmetazobactam, marking a pivotal ... Read More

FDA approves first generic RECTIV ointment by Cosette Pharmaceuticals

Pallavi Madhiraju- February 22, 2024 0

In a landmark move for the pharmaceutical industry, Cosette Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated ... Read More

Immune-Onc Therapeutics gets FDA orphan drug status for IO-202 in CMML

Pallavi Madhiraju- February 22, 2024 0

Immune-Onc Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapies in immunology and oncology, has achieved a significant milestone with the ... Read More

FDA approves Iovance’s AMTAGVI: A breakthrough in melanoma treatment

Pallavi Madhiraju- February 18, 2024 0

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a trailblazer in the field of biotechnology focused on developing novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies, has made ... Read More

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