US rejects MSD/Eisai’s Keytruda Lenvima combo
Regulators rejected accelerated approval as Roche’s combination for the same patient population made it over the line first
Read More
Tag: rejection
Tagrisso hit with NICE rejection for NSCLC
Unfortunately, the drug is not considered eligible for inclusion in the Cancer Drugs Fund either.
Read More
ViiV’s HIV regimen hit with setback in the US
US regulators have declined ViiV Healthcare’s application to market an investigational long-acting regimen for the treatment of HIV
Read More
Sarepta’s DMD drug hit with FDA Complete Response Letter
The company say they are “surprised” to have received the letter.
Read More
Nabriva hit with FDA rejection of Contempo for complicated urinary tract infections
The company cited issues related to facility inspections and manufacturing deficiencies at one contract manufacturer.
Read More
Novartis’ Kisqali hit with NICE rejection
The drug is typically used with fulvestrant to treat people with advanced breast cancer.
Read More
- MRM Health collaborates with Oncode Institute and Netherlands Cancer Institute
- Sobi to acquire Arthrosi Therapeutics, strengthening gout treatment pipeline
- Lindus Health and Quotient Sciences announce strategic partnership to accelerate drug development
- Title21 Health Solutions joins the Blood and Cells Advocacy Roster
- NADMED launches $30,000 metabolomics research award
