US FDA Nods BioMarin's Brineura For Children Under 3 years

BioMarin Pharmaceutical Inc. declared that the FDA has given the green light to the company's sBLA for Brineura to help delay the loss of walking ability in children with CLN2 disease, also known as TPP1 deficiency. Before, Brineura was approved...

UK MHRA Nods Pfizer/BioNTech's Covid-19 Vaccine for Adults, Children

UK MHRA has provided the approval to a modified Pfizer/BioNTech Covid-19 vaccine (Comirnaty) designed for the JN.1 Covid-19 subvariant. The vaccine stimulates the immune system to generate antibodies and blood cells to combat Covid-19...

Reunion Neuroscience Commences Patient dosing in phase 2 Trial of RE104

Neuroscience Inc., a company focused on advancing in neuroscience, revealed that the initial patient has received medication in the RECONNECT phase 2 trial of RE104 for postpartum depression (PPD) treatment. RE104 was created with the intention of...

Carbogen Amcis Concludes FDA Inspections at Two Manufacturing Sites

CARBOGEN AMCIS, a top pharmaceutical process development and API manufacturing company in Switzerland, has passed FDA inspections at its Neuland and Aarau locations. The FDA performed standard inspections in Neuland for five days from June 17-21...

Dren Bio and Novartis Partner to Develop Novel Targeted Myeloid Engagers

Dren Bio, Inc, a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, announced that it has entered into a strategic collaboration...

Novo Nordisk's Wegovy Receives UK Nod for Reducing Heart Risks

Wegovy, a weight-loss drug by Novo Nordisk, has been sanctioned approval by the UK regulator to help overweight and obese adults lower their risk of serious heart problems or strokes. The UK's Medicines and Healthcare products Regulatory Agency...

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