November 7, 2016
Bayer seeks approval for its liver cancer drug
Bayer on Monday announced the submission of applications to extend the marketing authorization for its oral multi-kinase inhibitor
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
November 7, 2016
Amryt gets FDA's designation for orphan drug to treat acromegaly
Amryt has received orphan drug designation from U.S. Food and Drug Administration (FDA) for its drug compound…
November 4, 2016
Lartruvo-soft tissue sarcoma drug to sell in U.S.
FDA granted accelerated approval to Lartruvo (olaratumab) injection, in combination with doxorubicin, for the treatment of adult patients…
November 2, 2016
India’s Ajanta gets green light for its high blood pressure generic
Ajanta Pharma has gotten US FDA’s approval to launch its high blood pressure tablets Amlodipine
November 2, 2016
India’s Koanna gets UK’s MHRA OK for Imatinib tablets
India’s Koanna gets marketing approval from MHRA for Imatinib tablets
November 1, 2016
Novartis gets FDA Priority Review for first-line treatment of advanced breast cancer
Novartis gets FDA Priority Review for first-line treatment of HR+/HER2-advanced breast cancer
October 31, 2016
FDA gives de novo approval for BD’s vaginitis detector
BD has gotten FDA market authorization for a first-of-its-kind molecular test…
October 31, 2016
Premaitha’s non-invasive prenatal test available on the NHS (UK)
Premaitha Health has gotten UK’s Department of Health approval to make non-invasive prenatal tests (“NIPT”)
October 31, 2016
Sanofi submits corrective action plan to the FDA regarding the BLA for sarilumab
Sanofi and Regeneron Pharmaceuticals have announced the FDA issued a Complete Response Letter (CRL) regarding…
October 31, 2016
Allergan’s chronic dry eye drops will make patients shed more tears
Allergan has received approval from the FDA for Restasis, treatment to help patients with a type of Chronic Dry Eye …