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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
March 30, 2021
NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.
March 29, 2021
Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.
March 15, 2021
FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.
A growing pipeline of gene therapy candidates aimed at treating neurodegenerative diseases has prompted new guidance.
March 01, 2021
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
February 26, 2021
EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.
February 17, 2021
The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).
February 12, 2021
The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.
January 22, 2021
Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.
January 21, 2021
The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.