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RSS FeedPosted by Michael Wonder on 22 Dec 2017
Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of Staphylococcus aureus bacteremia
21 December 2017 - Basilea Pharmaceutica announced today that the U.S. FDA designated its investigational drug ceftobiprole as a Qualified ...
Posted by Michael Wonder on 22 Dec 2017
U.S. FDA grants priority review to Janssen for apalutamide as a treatment for non-metastatic castration-resistant prostate cancer
21 December 2017 - Apalutamide is the first agent submitted for approval to treat earlier stage castration-resistant prostate cancer at high ...
Posted by Michael Wonder on 22 Dec 2017
FDA approves drug to treat dangerously low blood pressure
21 December 2017 - The U.S. FDA today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in ...
Posted by Michael Wonder on 21 Dec 2017
Diabetes is officially the messiest drug market
22 December 2017 - A crowded space gets more so as the FDA approves Pfizer/Merck's Steglujan. ...
Posted by Michael Wonder on 21 Dec 2017
FDA grants breakthrough therapy designation for alevumab in combination with Inlyta in advanced renal cell carcinoma
21 December 2017 - Second breakthrough therapy desgnation for avelumab in hard to treat cancer. ...
Posted by Michael Wonder on 21 Dec 2017
Samsung Bioepis’ SB3 trastuzumab biosimilar candidate accepted for review by the US FDA
20 December 2017 - Samsung Bioepis today announced that the US FDA has accepted for review the company’s biologics license application ...
Posted by Michael Wonder on 21 Dec 2017
FDA accepts new drug application for Seysara (sarecycline) for the treatment of moderate to severe acne
20 December 2017 - Allergan and Paratek Pharmaceuticals today announced that the U.S. FDA has accepted a new drug application to ...
Posted by Michael Wonder on 21 Dec 2017
Bayer announces initiation of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancers
20 December 2017 - Completion of NDA submission expected in early 2018. ...
Posted by Michael Wonder on 21 Dec 2017
FDA approves Genentech’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer
20 December 2017 - Accelerated approval of Perjeta for neo-adjuvant use also converted to full approval. ...
Posted by Michael Wonder on 21 Dec 2017
Aeterna Zentaris announces FDA approval of Macrilen (macimorelin) for diagnosis of adult growth hormone deficiency
20 December 2017 - Aeterna Zentaris announced today that the U.S. FDA has granted marketing approval for Macrilen (macimorelin), an orally ...
Posted by Michael Wonder on 21 Dec 2017
The Regulatory Accountability Act of 2017 — implications for FDA regulation and public health
20 December 2017 - In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme ...
Posted by Michael Wonder on 21 Dec 2017
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act Date for TX-004HR
20 December 2017 - PDUFA target action date of 29 May 2018. ...
Posted by Michael Wonder on 21 Dec 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease
20 December 2017 - Opdivo, the first and only anti-PD-1 immune checkpoint inhibitor approved for adjuvant treatment of melanoma, is indicated ...
Posted by Michael Wonder on 20 Dec 2017
U.S. Food and Drug Administration approves prior approval supplement for commercial launch of Portola Pharmaceuticals’ novel oral anti-coagulant Bevyxxa (betrixaban)
19 December 2017 - Bevyxxa available to patients in January 2018. ...
Posted by Michael Wonder on 20 Dec 2017
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) tablets for previously untreated advanced renal cell carcinoma
19 February 2017 - Approval expands indication and comes well in advance of PDUFA date of 15 February 2018. ...