GlobalData on MSN3d
Celltrion’s Avtozma receives FDA approval for multiple conditions
The FDA's approval is grounded in an evidence totality and comprehensive data package, which includes outcomes from a study.
Healio3d
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
GlobalData on MSN8d
FDA gives RMAT designation to Beacon’s retinitis pigmentosa treatment
The FDA has granted RMAT designation to Beacon Therapeutics’ gene therapy, laru-zova, for treating X-linked retinitis ...
PharmiWeb11d
GSK’s Shingrix new prefilled syringe presentation accepted for review by European Medicines Agency
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant ...
Beacon Therapeutics Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for laru-zova (AGTC-501)
Beacon Therapeutics Holdings Limited ('Beacon Therapeutics' or 'the Company'), a leading ophthalmic gene therapy company with ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
PMLiVE9d
Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA
Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
US FDA approves Novo Nordisk's Ozempic to reduce risk of kidney diseases in diabetic patients
Breakthrough in diabetes treatment! The US FDA approves Ozempic for reducing kidney disease risk in diabetic patients. Learn ...
EconoTimes9d
FDA Approves Ozempic for Kidney and Heart Protection in Diabetic Patients
The U.S. Food and Drug Administration (FDA) has approved Novo Nordisks (NYSE:NVO) Ozempic for reducing the risk of kidney ...
PoliticsHome1d
Britain’s medicines regulator is failing patients, innovators and the economy
Anthony Harnden took up his new role as the chair of the Medicines and Healthcare products Regulatory Agency (MHRA) at the ...
Healio15d
FDA grants fast-track designation to myotonic dystrophy type 1 treatment
The FDA has granted fast-track designation to an investigational antisense oligonucleotide to treat individuals with myotonic dystrophy type 1, or DM1, according to the manufacturer. In a press ...