United States FDA approves Teva's generic epinephrine injection auto-injector

16 August 2018 - Teva is pleased with the US FDA's approval of its generic versions of EpiPen and EpiPen ...

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FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication

21 August 2018 - The U.S. FDA today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending ...

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FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes

21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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