Blog
RSS FeedPosted by Michael Wonder on 15 Mar 2019
Spectrum Pharmaceuticals provides BLA filing update for Rolontis (eflapegrastim)
15 March 2019 - Spectrum Pharmaceuticals announced today that due to the U.S. FDA's request for additional manufacturing-related information for ...
Posted by Michael Wonder on 15 Mar 2019
Eton Pharmaceuticals submits new drug application for DS-200
14 March 2019 - FDA previously granted DS-200 fast track designation. ...
Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...
Posted by Michael Wonder on 14 Mar 2019
Patient advocates applaud Cancer Drug Parity Act filed in both the U.S. House and Senate
13 March 2019 - The Coalition to Improve Access to Cancer Care and its members from across the cancer patient ...
Posted by Michael Wonder on 14 Mar 2019
Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development
14 March 2019 - Modernizing clinical trials is an agency wide priority. ...
Posted by Michael Wonder on 14 Mar 2019
How Eli Lilly’s new generic insulin could impact prices across the market
14 March 2019 - The list price is $137.35 per vial. ...
Posted by Michael Wonder on 14 Mar 2019
FDA grants Purdue Pharma’s nalmefene hydrochloride injection fast track designation for the emergency treatment of known or suspected opioid overdose
13 March 2019 - Committed to advancing solutions to the opioid public health crisis, Purdue will not profit from nalmefene hydrochloride. ...
Posted by Michael Wonder on 13 Mar 2019
FDA medical adviser: 'Congress is owned by pharma'
13 March 2019 - Pharmaceutical companies are under the spotlight with congressional hearings on the cost of drug prices and ...
Posted by Michael Wonder on 13 Mar 2019
Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...
Posted by Michael Wonder on 13 Mar 2019
Janssen submits application to U.S. FDA seeking approval of Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
12 March 2019 - Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot ...
Posted by Michael Wonder on 13 Mar 2019
Aerie Pharmaceuticals announces U.S. FDA approval of Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
12 March 2019 - Aerie Pharmaceuticals today announced that the U.S. FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves a new generic valsartan
12 March 2019 - Today, the U.S. FDA approved a new generic of Diovan (valsartan). ...
Posted by Michael Wonder on 12 Mar 2019
Cancer Institute's Sharpless tapped as acting chief of FDA
12 March 2019 - Ned Sharpless, the director of the National Cancer Institute, will be named temporary chief of the ...
Posted by Michael Wonder on 12 Mar 2019
U.S. FDA approves Pfizer's oncology biosimilar Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin
11 March 2019 - Pfizer today announced the United States FDA has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
11 March 2019 - Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation ...