schizophrenia

May 02, 2023

FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...

Jan 17, 2023

FDA Approves Luye Pharma’s Rykindo for Schizophrenia Luye Pharma has received its first FDA approval for Rykindo, an injectable formulation of the antipsychotic risperidone administered every two weeks. Rykindo has been approved by the US Food and Drug Administration for the treatment of schizophrenia as well as...

Apr 12, 2022

FDA Approves BioXcel’s Agitation Drug Igalmi BioXcel Therapeutics has received FDA clearance for its first drug, Igalmi, as a treatment for agitation in persons with Schizophrenia or Bipolar Disorder. Igalmi (dexmedetomidine) is the first drug approved for this application that comes in the form of a tablet that...

Nov 01, 2021

Progress is driven by innovation. When it comes to developing novel medications and therapeutic biological products, the FDA's Center for Drug Evaluation and Research (CDER) assists the pharmaceutical sector at every stage of the process. CDER offers scientific and regulatory assistance needed to bring innovative m...

Feb 02, 2021

Horizon Therapeutics Bolsters its Rare Disease Portfolio in a $3B Viela Bio Buyout Horizon Therapeutics has announced to acquire Viela Bio for about $3.1 billion to augment its portfolio and pipeline of treatments for rare diseases. The shares of Viela Bio skyrocketed more than 52% in premarket trading after the...

Dec 17, 2020

Mitochondria destruction can help in Cancer Treatment  Human cells require structures known as mitochondria for the generation of energy for their biochemical activities. Researchers at the Karolinska Institutet in Sweden thought that destroying these could be a strategy for cancer treatment.  Follo...

May 05, 2020

Florence-based Menarini Group has announced a USD667 million acquisition of the Stemline Therapeutics, an oncology-focused company. As per the agreement, Menarini plans to help Stemline to build a strong foothold in the U.S., and will also continue the development of Elzonris, a CD123 targeted therapy. Th...

Oct 31, 2019

AstraZeneca has announced the licensing-out of two of its drugs Seroquel and Seroquel XR in Europe and Russia to Cheplapharm Arzneimittel GmbH. According to the deal signed between the companies, AZ will receive an upfront payment of USD 178 Million, in addition to other payments upon achieving sales milestones...

Jul 17, 2018

Alkermes Gets FDA approval for Aristada Initio (aripiprazole lauroxil) as Part of  Schizophrenia Treatment Combination  Alkermes has announced that the U.S. FDA approved ARISTADA INITIO (aripiprazole lauroxil) for the initiation of ARISTADA (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic f...

Mar 15, 2018

M&A activity of Sanofi and Bioverative for rare blood diseases Sanofi has strengthened its position in hematology & speciality medicine by acquiring Bioverativ, Biogen hemophilia & blood disorders-focused company for USD 105 per share on March 8, 2018. This will increase Sanofi’s hemophilia portfolio for...