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RSS FeedPosted by Michael Wonder on 06 Mar 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) now the first and only FDA approved PD-1 inhibitor to offer every four week dosing
6 March 2018 - Opdivo also now approved for shorter 30-minute infusions, cutting previous infusion time in half ...
Posted by Michael Wonder on 06 Mar 2018
FDA authorises, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
6 March 2018 - Test only reports 3 out of more than 1,000 known BRCA mutations and negative result doesn’t rule ...
Posted by Michael Wonder on 03 Mar 2018
Otonomy announces FDA approval of Otiprio for acute otitis externa
2 March 2018 - Otonomy today announced that the U.S. FDA has approved Otiprio (ciprofloxacin 6% otic suspension) for the treatment ...
Posted by Michael Wonder on 01 Mar 2018
Sorrento Therapeutics subsidiary, Scilex, receives US FDA approval for non-opioid ZTlido (lignocaine topical system) 1.8% for PHN pain
28 February 2018 - ZTlido uses novel technology demonstrating 12 hour wear for efficient lignocaine delivery, even during exercise. ...
Posted by Michael Wonder on 28 Feb 2018
European Commission approves Roche's Hemlibra for people with haemophilia A with inhibitors
27 February 2018 - First new medicine in over 20 years to treat people with haemophilia A with inhibitors in Europe. ...
Posted by Michael Wonder on 27 Feb 2018
Health Canada has approved Fasenra (benralizumab injection) for patients with severe eosinophilic asthma
26 February 2018 - AstraZeneca Canada today announced that Health Canada has approved Fasenra (benralizumab injection) as an add-on maintenance treatment ...
Posted by Michael Wonder on 27 Feb 2018
Lilly receives additional FDA approval for Verzenio (abemaciclib), as initial treatment for advanced breast cancer
26 February 2018 - New indication based on MONARCH 3 trial can help more women living with HR+, HER2- advanced breast ...
Posted by Michael Wonder on 26 Feb 2018
EU clears rare musculoskeletal disorder drug
26 February 2018 - Doctors can now treat children living in the EU with the rare, chronic progressive musculoskeletal disorder ...
Posted by Michael Wonder on 26 Feb 2018
Lynparza receives positive EU CHMP opinion in platinum-sensitive relapsed ovarian cancer
23 February 2018 - AstraZeneca and MSD’s new Lynparza tablet formulation recommended for maintenance therapy regardless of BRCA status. ...
Posted by Michael Wonder on 24 Feb 2018
KemPharm announces FDA approval of Apadaz (benzhydrocodone and paracetamol) for the short-term management of acute pain
23 February 2018 - Apadaz is the first pro-drug of hydrocodone/paracetamol to be approved by FDA. ...
Posted by Michael Wonder on 24 Feb 2018
Puma Biotechnology receives results of CHMP formal decision for neratinib for extended adjuvant treatment of HER2-positive early stage breast cancer
23 February 2018 - Puma Biotechnology announced that the CHMP of the EMA has adopted a negative opinion, recommending the ...
Posted by Michael Wonder on 24 Feb 2018
Pfizer announces update on European marketing authorisation application for Sutent (sunitinib) in adult patients at high risk of recurrent renal cell carcinoma
23 February 2018 - Pfizer today announced that the CHMP of the EMA has recommended against expanding use of Sutent ...
Posted by Michael Wonder on 24 Feb 2018
Pfizer receives positive CHMP opinion for two haematology medicines, Mylotarg and Bosulif
23 February 2018 - Pfizer today announced that the CHMP of the EMA has adopted positive opinions recommending that two Pfizer ...
Posted by Michael Wonder on 24 Feb 2018
Highlights from February 2018 CHMP meeting
23 February 2018 - Five medicines recommended for approval, including two orphans. ...
Posted by Michael Wonder on 23 Feb 2018
Health Canada approves Bavencio (avelumab for injection) for the treatment of metastatic Merkel cell carcinoma in previously treated adult patients
22 February 2018 - First Health Canada approved treatment for rare and aggressive type of skin cancer. ...