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RSS FeedPosted by Michael Wonder on 17 Oct 2019
Genentech announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications
17 October 2019 - Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of ...
Posted by Michael Wonder on 17 Oct 2019
Pelosi’s drug pricing plan puts medical innovation at risk
17 October 2019 - The future of medical innovation in America is at a crossroads. ...
Posted by Michael Wonder on 17 Oct 2019
Trastuzumab deruxtecan (DS-8201) granted FDA priority review for treatment of patients with HER2 positive metastatic breast cancer
17 October 2019 - Daiichi Sankyo and AstraZeneca today announced that the U.S. FDA has accepted for review the biologics ...
Posted by Michael Wonder on 16 Oct 2019
Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs
16 October 2019 - FDA generic drug approvals reach record high in fiscal year 2019. ...
Posted by Michael Wonder on 16 Oct 2019
ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1
16 October 2019 - ViiV Healthcare announced the submission of a supplemental New Drug Application to the US FDA for ...
Posted by Michael Wonder on 16 Oct 2019
RWE to supplement RCTs: FDA projects continue
15 October 2019 - The US FDA has been working with several different data and research companies to further its ...
Posted by Michael Wonder on 16 Oct 2019
Health Canada approves Ipsen's Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma
15 October 2019 - Cabometyx demonstrated a statistically significant, 52% reduction in the risk of progression or death compared with sunitinib, ...
Posted by Michael Wonder on 16 Oct 2019
First Algenex CrisBio-based vaccine submitted to European Medicines Agency
15 October 2019 - Potential approval would validate the use of Algenex’ CrisBio technology for the manufacture of recombinant subunit vaccines. ...
Posted by Michael Wonder on 16 Oct 2019
ProQR receives rare paediatric disease designation from FDA for sepofarsen for the treatment of LCA10
15 October 2019 - ProQR Therapeutics today announced that it received rare paediatric disease designation from the U.S. FDA for ...
Posted by Michael Wonder on 15 Oct 2019
Wanted: better policies and incentives to revitalise R&D for new antimicrobial drugs
15 October 2019 - In the not-too-distant future that we could be facing — one with rampant, uncontrollable, multidrug-resistant microbes ...
Posted by Michael Wonder on 15 Oct 2019
Faced with a drug shortfall, doctors scramble to treat children with cancer
14 October 2019 - A critical chemotherapy medication is in short supply, and physicians say there is no appropriate substitute. ...
Posted by Michael Wonder on 15 Oct 2019
U.S. FDA approves Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia
15 October 2019 - Noven Pharmaceuticals today announced the U.S. FDA has approved Secuado (asenapine) transdermal system, the first-and-only transdermal patch ...
Posted by Michael Wonder on 15 Oct 2019
Patient experience data: researchers call for more consistency from FDA
14 October 2019 - Researchers at drug maker Sanofi are calling on the US FDA to make its publication of ...
Posted by Michael Wonder on 15 Oct 2019
Xenikos receives FDA fast track designation for T-Guard(R) for treating steroid-refractory acute graft-versus-host disease
14 October 2019 - Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial. ...
Posted by Michael Wonder on 15 Oct 2019
Akorn receives FDA approval for betamethasone dipropionate 0.05% lotion USP (augmented)
14 October 2019 - Akorn today announced that it received a new abbreviated new drug application approval from the U.S. ...