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Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines
The Nobel Prize in Physiology and Medicine has been awarded to two scientists whose research allowed for the development of …
Basilea pre-emptively seeks US partner for ceftobiprole as FDA accepts NDA
The US Food and Drug Administration (FDA) has accepted Basilea Pharmaceutica’s new drug application (NDA) for ceftobiprole, with the agency …
FDA approves Empaveli injector for PNH patients
The US Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals’ Empaveli injector (Enfuse) for the subcutaneous delivery of Empaveli …
Biogen edges out competition to win first FDA approval for Actemra biosimilar
Biogen has entered the crowded arthritis market in the US following approval of its biosimilar Tofidence (tocilizumab-bavi) by the US …
FDA lifts partial hold on Phase III plans for rare ataxia drug
Quince Therapeutics has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on …
FDA approves Empaveli injector for PNH patients
The US Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals’ Empaveli injector (Enfuse) for the subcutaneous delivery of Empaveli …
Biogen edges out competition to win first FDA approval for Actemra biosimilar
Biogen has entered the crowded arthritis market in the US following approval of its biosimilar Tofidence (tocilizumab-bavi) by the US …
FDA lifts partial hold on Phase III plans for rare ataxia drug
Quince Therapeutics has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on …
Novartis eyes accelerated FDA approval for iptacopan across multiple indications
Novartis has announced positive interim results for iptacopan from the Phase III Applause-IgAN study showing significant proteinuria reduction in patients …
First 10 drugs for Medicare price negotiation may see minimal commercial impact
The Biden Administration has released the highly anticipated list of 10 drugs selected for Medicare price negotiations under the US …
Regeneron’s bispecific lymphoma antibody odronextamab wins FDA priority review
The US Food and Drug Administration (FDA) has accepted the priority review of the biologics license application (BLA) for Regeneron …
Cambridge biotech Thymmune wins $37m NIH grant for thymic cell therapies
The US Department of Health and Human Services has awarded $37m in funding to Thymmune Therapeutics to accelerate the startup …
Karuna Therapeutics files for FDA approval for schizophrenia treatment
Karuna Therapeutics has announced the submission of a new drug application (NDA) to the US Food and Drug Administration for …
ModeX wins $168m BARDA contract to develop viral antibody therapies
The US Biomedical Advanced Research and Development Authority (BARDA) has awarded a $168m Project NextGen contract to ModeX Therapeutics to …
Can reforms restore faith in India’s pharma industry after cough syrup scandals?
India is known as the 'pharmacy of the world', producing a substantial quantity of generic drugs globally. However, its lax …