Pfizer Inc. has reported strong topline results from its phase 3 MagnetisMM-5 study, signaling a potential shift in myeloma treatment for patients with relapsed or refractory disease. The trial showed that Elrexfio significantly improved...
Abbott announced it has secured U.S. Food and Drug Administration clearance and CE Mark approval for its latest OCT imaging system, Ultreon 3.0, signaling a major move in complex coronary care. The platform combines high-resolution imaging with...
Solara Active Pharma Sciences has successfully cleared a US FDA inspection at its Puducherry manufacturing plant, earning a Voluntary Action Indicated (VAI) status and reinforcing its compliance with global pharmaceutical quality standar...
Global pharma giant AstraZeneca has achieved a major milestone with the Breztri Aerosphere asthma FDA approval, expanding treatment options for asthma patients worldwide. The U.S. Food and Drug Administration (FDA) has approved the..
Johnson & Johnson is using AI to accelerate drug discovery efforts, saying the technology has cut the time needed to generate early-stage drug development leads by half. The company revealed that AI drug discovery tools are helping researchers...
The European Commission has approved Novartis Rhapsido (remibrutinib treatment) for adults suffering from chronic spontaneous urticaria (CSU treatment) who do not respond well to antihistamines. The European Commission approval gives patien...
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) to market Fingolimod Capsules 0.5 mg in the United States. The approval marks another important step in the company’s efforts to strength...
Jennifer Li, SVP, Head of APAC Sales, Medidata, engaged in a conversation with Thiruamuthan, Assistant Editor at India Pharma Outlook, discusses how AI is transforming clinical trials in India by accelerating patient recruitment, enhancing data
Indian drugmaker Cipla has received approval from the USFDA approval process for a generic respiratory inhaler used to treat breathing-related conditions. The approval strengthens the company’s growing presence in the U.S. pharmaceutical mark...
Novo Nordisk reported positive Phase 3 results today for its semaglutide pill, marking a key step toward expanding diabetes treatment for younger patients. The late-stage trial, known as PIONEER TEENS, tested the oral drug in children aged...