-
FDA Rejects Oral Cladribine
The US Food and Drug Administration (FDA) wants more information about Cladribine, an oral treatment for multiple sclerosis developed by Merck KGaA The European Medicines Agency (EMEA) [...]
-
EU Rejects Merck’s Multiple-Sclerosis Pill, Cladribine
Merck KGaA’s hopes of gaining European marketing approval for its multiple-sclerosis pill Cladribine were quashed Friday, after a European Union panel confirmed its negative opinion on the [...]
-
FDA Delays Approval of Oral Cladribine for 3 Months
The Food and Drug Administration extended the pill’s priority review period by three months to Feb. 28, 2011, to examine additional information on the product, Darmstadt, Germany-based [...]
-
Merck to Appeal Negative Panel View on Cladribine
Merck KGaA (MRK.XE) said Monday it plans to appeal the negative assessment reached by a European drug advisory panel on the use of its new multiple sclerosis [...]
-
Physicians Eager to Embrace Orals (the MS orals, not the other kind)
Physicians are anticipating the arrival of new oral therapies for multiple sclerosis patients, with initial research showing very high awareness of oral candidates, particularly Novartis’ Gilenya, which [...]
-
HOT off the EFNS Press: PWMS Treated With Cladribine Remain Progression-Free
September 29, 2010 — A large proportion of patients with relapsing-remitting multiple sclerosis (MS) remained relapse-free following cladribine treatment at either of 2 dose levels, according to [...]
-
Merck May Appeal EMA Negative Cladribine Opinion
Merck may appeal a negative opinion on its multiple sclerosis pill Cladribine made by an advisory panel of the European Medicines Agency, Merck KGaA said Friday. The [...]
-
Movectro (oral cladribine) Approved in AUSTRALIA
Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be registered [...]
-
Study finds that most neurologists plan to prescribe oral MS drugs when approved this year
Majestic Research Study Indicates that Neurologists’ Apprehension Regarding Side Effects Won’t Stop Them from Prescribing New Oral MS Drugs, but Concerns Will Likely Relegate Their Use to [...]
-
FDA Grants Cladribine Priority Review
July 28 (Bloomberg) — Merck KGaA said U.S. regulators granted the cladribine multiple sclerosis pill priority review, reducing to six months from 10 the time it will [...]
-
-
-
-
-
-
-
-
-



