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Alcobra submits protocol to US FDA for Phase IIb MDX trial to treat Fragile X SyndromeIsrael-based biopharmaceutical firm Alcobra has submitted a protocol to the US Food and Drug Administration (FDA) for a Phase IIb clinical trial of its proprietary drug candidate Metadoxine Extended R2014/4/14
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Pharmacyclics submits sNDA to FDA for leukaemia drug ImbruvicaPharmacyclics, collaboration partner of Janssen Research & Development (Janssen), has submitted a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) to the US Food and Drug Adminis2014/4/14
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Eli Lilly and T1D Exchange partner to support type 1 diabetes patientsEli Lilly and Company and T1D Exchange have entered into a research collaboration to discover new ways to improve care and advance outcomes for patients with type 1 diabetes (T1D). The collaboration2014/4/11
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FDA grants priority review for Gilead's hepatitis C combination therapyThe US Food and Drug Administration (FDA) has granted priority review to Gilead Sciences' new drug application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg2014/4/11
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Scottish Medicines Consortium issues positive advice for Actelion's PAH drug OpsumitActelion Pharmaceutical UK's new endothelin receptor antagonist Opsumit (macitentan) is now available through NHS Scotland as monotherapy or in combination, for the long-term treatment of pulmonary ar2014/4/10
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FDA grants priority review for Gilead's hepatitis C combination therapyThe US Food and Drug Administration (FDA) has granted priority review to Gilead Sciences' new drug application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg2014/4/10
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Merck, Ferring and WHO team-up for new anti-bleeding drugMerck and Ferring Pharmaceuticals have entered into collaboration with the World Health Organization (WHO) to advance a new, proprietary formulation of carbetocin, used to prevent excessive bleeding (2014/4/9
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Astellas submits MAA for wider use of prostate cancer drug Xtandi in EuropeAstellas Pharma and Medivation have submitted a variation to amend the European marketing authorisation application (MAA) for Xtandi (enzalutamide) capsules to treat adult men with metastatic castrati2014/4/9
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Critical Outcome seeks FDA orphan drug status for ovarian cancer drug COTI-2Canada-based bioinformatics and accelerated drug discovery firm Critical Outcome Technologies (COTI) has submitted an orphan drug application to the US Food and Drug Administration (FDA) for its lead2014/4/8
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FDA Approves New Hand-Held Auto-Injector to Reverse Opioid Overdose‏Yesterday (3 April)FDAapproved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochlor2014/4/8