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3793 News Found

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection
Drug Approval | October 24, 2025

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable


Glenmark Pharmaceuticals USA to launch Ropivacaine Hydrochloride Injection USP
News | October 23, 2025

Glenmark Pharmaceuticals USA to launch Ropivacaine Hydrochloride Injection USP

Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA


Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline
News | October 23, 2025

Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline

The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A


Takeda and Innovent Biologics forge global partnership to advance oncology medicines for solid tumors
News | October 23, 2025

Takeda and Innovent Biologics forge global partnership to advance oncology medicines for solid tumors

Takeda will make an upfront payment of $1.2 billion, which includes a $100 million equity investment in Innovent


FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer
Drug Approval | October 23, 2025

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial


Pimicotinib delivers lasting tumor responses and sustained symptom relief in TGCT patients
Clinical Trials | October 23, 2025

Pimicotinib delivers lasting tumor responses and sustained symptom relief in TGCT patients

Global Phase 3 MANEUVER study highlights ongoing benefits and consistent safety profile


Merck breaks ground on $3 billion center of excellence for pharma manufacturing in Virginia
News | October 22, 2025

Merck breaks ground on $3 billion center of excellence for pharma manufacturing in Virginia

The expansion underscores Merck’s commitment to invest more than $70 billion in U.S. research, development and capital projects


Qure.ai receives regulatory clearance for AI tool for early detection of TB in children below 3 years
Technology | October 22, 2025

Qure.ai receives regulatory clearance for AI tool for early detection of TB in children below 3 years

Breakthrough expands proactive TB screening from birth to 15 years, ensuring faster and more accurate diagnosis


Cambrex to invest $120 million to expand API manufacturing in US
News | October 22, 2025

Cambrex to invest $120 million to expand API manufacturing in US

Expanding US operations to address the increased demand for API development and manufacturing


FDA approves Tezspire for chronic rhinosinusitis with nasal polyps
Drug Approval | October 21, 2025

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation