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The FDA has approved Swiss drugmaker Novartis’ long-acting-release form of Signifor to treat the rare and life-threatening hormonal disorder acromegaly, following its approval in Europe last month. Read More
European regulators have selected nine applicants out of 29 manufacturers who submitted proposals to participate in the EMA’s adaptive pathway pilot project, which aims to speed drug approvals by authorizing products in stages for targeted populations. Read More
Novartis’ cancer drug Afinitor failed to significantly increase survival rates for patients with a rare type of advanced breast cancer, casting further doubt on the drugmaker’s efforts to expand uses of the blockbuster therapy. Read More
British healthcare cost evaluators have reversed course and are now recommending reimbursement for three ulcerative colitis drugs: AbbVie’s Humira and Merck’s Remicade and Simponi. Read More
A German healthcare watchdog questioned the efficacy of Bayer’s Eylea for a third time, which could affect the reimbursement price of the profitable eye drug. Read More
The FDA has approved 35 novel new drugs so far this year, up from 27 products last year, with officials touting 2014 as the best year ever for rare disease treatment approvals. Read More
Merck’s new Gardasil 9 human papillomavirus vaccine won FDA approval to prevent various cancers and other illnesses caused by the sexually transmitted disease in young men and women. Read More
Central nervous system drugs that treat conditions such as Alzheimer’s and Parkinson’s disease lag behind other drugs in clinical development and approval times, a recent report finds. Read More
The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More
A House bill would for the first time require drugmakers to create and disclose an expanded access policy in exchange for receiving breakthrough therapy designation, redeeming a priority review voucher or having the drug become a qualified infectious disease product. Read More
European regulators have approved AstraZeneca and Nektar Therapeutics’ opioid-induced constipation drug Moventig for adults that have not responded to laxatives. Read More