Kala Pharmaceuticals announced that it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the company’s new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has refused to recommend approval for Amgen and UCB’s Evenity (romosozumab) for the treatment of severe osteoporosis.
The US Food & Drug Administration (FDA) has refused to give its approval to Motif Bio’s skin disorder drug iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The US Food and Drug Administration has posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.
The US Food and Drug Administration has refused to approve Regeneron’s pre-filled syringe version of eye-drug Eylea (aflibercept).
The US Food and Drug Administration (FDA) has refused to approve the use of GlaxoSmithKline’s mepolizumab for treating patients with chronic obstructive pulmonary disease (COPD) on grounds of needing more clinical data.
Sunovion Pharmaceuticals has failed to get approval from the US Food and Drug Administration (FDA) for dasotraline to treat attention-deficit hyperactivity disorder (ADHD).
The Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending GlaxoSmithKline’s (GSK) mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.
The US Food and Drug Administration (FDA) has declined to approve Evolus' application seeking approval of DWP-450 to treat glabellar lines in adult patients.
The US Food and Drug Administration (FDA) has refused to approve Lipocine's Tlando, an oral testosterone product candidate for testosterone replacement therapy (TRT).
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