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December 12, 2019
Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.
The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.
December 06, 2019
The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.
November 20, 2019
The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.
The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.
The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.
November 15, 2019
Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.
November 14, 2019
The recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.
NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.
November 12, 2019
Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.