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RSS FeedPosted by Michael Wonder on 21 Aug 2018
FDA kicks off effort to examine importing drugs
20 August 2018 - A controversial FDA working group has begun discussing how to import drugs from other countries as ...
Posted by Michael Wonder on 21 Aug 2018
FDA approves expanded label for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
20 August 2018 - Approval based on results of KEYNOTE-189, where Keytruda in combination with pemetrexed and platinum chemotherapy reduced the ...
Posted by Michael Wonder on 21 Aug 2018
FDA accepts priority review of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the US
20 August 2018 - EU filing accepted and under review. ...
Posted by Michael Wonder on 21 Aug 2018
MeiraGTx announces AAV-CNGB3 granted fast track designation by U.S. FDA for treatment of achromatopsia
20 August 2018 - MeiraGTx today announced that the U.S. FDA has granted fast track designation for its AAV-CNGB3 gene therapy ...
Posted by Michael Wonder on 20 Aug 2018
U.S. FDA grants fast track designation to Aravive Biologics’ AVB-S6-500
20 August 2018 - Aravive Biologics announced today that the U.S. FDA has granted fast track designation to AVB-S6-500 as a ...
Posted by Michael Wonder on 20 Aug 2018
Wave Life Sciences receives US orphan drug and rare paediatric disease designations for WVE-210201
16 August 2018 - Wave Life Sciences today announced that the U.S. FDA has granted both orphan drug designation and rare ...
Posted by Michael Wonder on 17 Aug 2018
FDA approves Eylea (aflibercept) injection sBLA in wet age-related macular degeneration
17 August 2018 - Regeneron Pharmaceuticals today announced that the U.S. FDA has approved a supplemental biologics license application for ...
Posted by Michael Wonder on 17 Aug 2018
U.S. FDA approves Opdivo (nivolumab) as the first new medication in nearly 20 years for certain patients with previously treated small cell lung cancer
17 August 2018 - Opdivo is now the first immuno-oncology treatment approved for small cell lung cancer patients who received platinum-based ...
Posted by Michael Wonder on 17 Aug 2018
FDA approves generic EpiPen that may be cheaper
16 August 2018 - The FDA on Thursday approved the first generic version of EpiPen, providing new competition that could ...
Posted by Michael Wonder on 17 Aug 2018
Eisai and Merck announce FDA approval of Lenvima (lenvatinib) capsules for first-line treatment of unresectable hepatocellular carcinoma
16 August 2018 - Approval was based on REFLECT, the first-ever positive Phase 3 trial against an active comparator in previously ...
Posted by Michael Wonder on 17 Aug 2018
Sun Pharma announces U.S. FDA approval of Cequa to treat dry eye disease
16 August 2018 - Cequa (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye ...
Posted by Michael Wonder on 16 Aug 2018
How disruptive innovation by business and technology firms could improve population health
16 August 2018 - In 1990 the Centers for Disease Control and the US Preventive Services Task Force launched Healthy ...
Posted by Michael Wonder on 16 Aug 2018
Statement from FDA Commissioner on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
16 August 2018 - Over the last several years, there’s been growing scientific and public interest in the role of microorganisms ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves first generic version of EpiPen
16 August 2018 - The U.S. FDA today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for ...
Posted by Michael Wonder on 16 Aug 2018
Ortho Dermatologics resubmits U.S. new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
15 August 2018 - Ortho Dermatologics, a division of Bausch Health, today announced it has resubmitted a new drug application to ...