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FDA Approves Ozempic (semaglutide) injection 0.5mg/1mg, a once-weekly, Novo Nordisk
semaglutide is glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Lilly chases Amgen with migraine drug filin
Novartis and Amgen already filed their migraine drug Aimovig (erenumab) with the FDA, the first from the calcitonin gene-related peptide (CGRP) inhibitor class, Lilly has now had its filing for its rival CGRP accepted by the FDA
Pfizer first Janus kinase inhibitor approved by the FDA for moderate to severe rheumatoid arthritis
5 mg twice-daily tofacitinib (XELJANZ) and an extended release once-daily therapy (XELJANZ XR) is used for the treatment of adult patients with active psoriatic arthritis (PsA) who have had inadequate response or intolerance to disease-modifying antirheumatic drugs (DMARDs).
New FDA efforts to support more efficient develoent of targeted therapy
Identification of Patients for Inclusion in Clinical Trials
2. General approaches to evaluating the benefits and risks of targeted therapies within a clinically defined disease where some molecular alterations may occur at low frequency.
Reducing the hurdles for complex generic drug development
FDA is issuing a draft guidance to assist ANDA applicants and prospective ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors looking to develop complex generic drugs.
FDA Makes Side-Effect Database Searchable
Side effects filed by patients and doctors, making it easily searchable by product, patient age, type of side effect or year it occurred.
The FDA Is Approving Drugs at a Staggering Pace
Thirty-four new drugs -- treating everything from cancer to rare genetic diseases -- have been approved so far this year.
FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program
FDA plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children.
FD (11th): ANDA Submissions – Refuse to Receive (RTR) Guidance for Industry
Failed Clinical(BE) Studies must be submitted, but An ANDA will be Refused for Receipt if only a failed study is submitted.