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RSS FeedPosted by Michael Wonder on 31 Oct 2018
Industry group wants FDA to stop drug importation study
31 October 2018 - A coalition of insurers and drug manufacturers wants the Trump administration to stop its research into ...
Posted by Michael Wonder on 31 Oct 2018
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz)
31 October 2018 - Biosimilar Hyrimoz (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity. ...
Posted by Michael Wonder on 31 Oct 2018
FDA approves Merck’s Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer
30 October 2018 - First anti-PD-1 approved for first-line treatment of squamous non-small cell lung cancer regardless of PD-L1 expression. ...
Posted by Michael Wonder on 31 Oct 2018
FDA grants priority review for Sanofi's dengue vaccine candidate
31 October 2018 - The United States FDA has accepted a biologics license application for Sanofi Pasteur's dengue vaccine. ...
Posted by Michael Wonder on 31 Oct 2018
FDA grants breakthrough therapy designation for UroGen Pharma’s UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer
30 October 2018 - On track to initiate rolling submission of UGN-101 new drug application in Q4 2018. ...
Posted by Michael Wonder on 30 Oct 2018
U.S. FDA approves Invokana (canagliflozin) to reduce the risk of heart attack, stroke or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease
30 October 2018 - Invokana is now the only oral diabetes treatment approved to reduce the risk of these cardiovascular events. ...
Posted by Michael Wonder on 30 Oct 2018
Acer Therapeutics submits NDA for Edsivo for the treatment of vEDS
29 October 2018 - Acer Therapeutics today announced that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 29 Oct 2018
Jazz Pharmaceuticals announces FDA approval of Xyrem (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in paediatric narcolepsy patients
29 October 2018 - This approval of Xyrem by the FDA marks the first medicine approved to treat cataplexy or excessive ...
Posted by Michael Wonder on 29 Oct 2018
TherapeuticsMD announces FDA approval of TX-001HR: Bijuva (oestradiol and progesterone) capsules for the treatment of moderate to severe vasomotor symptoms due to menopause
29 October 2018 - BIJUVA is the first and only FDA approved hormone therapy of bio-identical oestradiol in combination with bio-identical ...
Posted by Michael Wonder on 29 Oct 2018
Xeris Pharmaceuticals announces FDA acceptance for review of NDA for its ready-to-use glucagon rescue pen
23 October 2018 - If approved, the Xeris glucagon rescue pen would be the first ready-to-use, room-temperature stable liquid glucagon in ...
Posted by Michael Wonder on 28 Oct 2018
FDA accepts supplemental new drug application for Lonsurf (trifluridine/tipiracil) for the treatment of metastatic gastric/gastro-oesophageal junction adenocarcinoma; grants priority review
26 October 2018 - Taiho Pharmaceutical today announced that the United States FDA has accepted and granted priority review for ...
Posted by Michael Wonder on 28 Oct 2018
U.S. FDA approves expansion of Trintellix (vortioxetine) label
22 October 2018 - Lundbeck and its partner Takeda can once again expand the Clinical Trials section of the U.S. ...
Posted by Michael Wonder on 25 Oct 2018
FDA's Gottlieb 'extremely worried' on CAR-T reimbursement
24 October 2018 - FDA Commissioner Scott Gottlieb stressed the need for reform on the reimbursement side of medicine, calling it ...
Posted by Michael Wonder on 25 Oct 2018
Pharmaceutical industry challenges Trump plan forcing companies to reveal drug prices in TV ads
25 October 2018 - Symbicort, an inhaler marketed to people whose lung disease makes them “huff and puff,” rolls off ...
Posted by Michael Wonder on 25 Oct 2018
FDA declines to approve pre-filled syringe version of Regeneron's Eylea
25 October 2018 - Regeneron Pharmaceuticals said on Thursday the U.S. FDA declined to approve a pre-filled syringe version of ...