RSS

Positive opinion

RNAi therapeutics company, Alnylam Pharmaceuticals, has revealed that the CHMP has adopted a positive opinion on the use of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or 2 polyneuropathy Read more

News

Cablivi (caplacizumab) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of a rare blood-clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP) Read more

News

Akcea Therapeutics, has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the use of its orphan drug for the treatment of Stage 1 or Stage 2 polyneuropathy in adults with hereditary Read more

News

A positive opinion has been adopted by the CHMP of the European Medicines Agency, recommending a change to the terms of the marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) to include first-line treatment. Read more

News

Amgen and Allergan have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorisation of ABP 980, a biosimilar to Herceptin (trastuzumab). Read more

News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Juluca treatment for HIV-1. Read more

News

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the marketing authorisation of Lynparza (olaparib) tablets for patients with platinum-sensitive relapsed ovarian, fallopian tube, or primary perito Read more

News

The EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra (emicizumab) — Roche’s prophylactic treatment for people with haemophilia A with inhibitors. Read more

News

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the marketing authorisation in the EU for Janssen-Cilag International’s guselkumab — a treatment for moderate to severe plaque psoriasis. Read more

News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for a once-daily darunavir-based single tablet regimen (STR) for the treatment of HIV. Read more

News

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion, recommending that biosimilar Imraldi be granted marketing authorisation. Read more

News

Merck has announced that the CHMP of the EMA has issued a positive opinion for approval of Cladribine tablets for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity. Read more

News

Sanofi and Regeneron have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation of Kevzara (sarilumab). Read more

News

The CHMP has given a positive opinion recommending that Biogen’s treatment for patients with spinal muscular atrophy (SMA), SPINRAZA (nusinersen), be granted marketing authorisation. Read more

News