GW Pharmaceuticals plc , a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for… read more.
Kite, a Gilead Company announced that the FDA has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma… read more.
The FDA approved Pfizer Inc.’s supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small… read more.
Gilead Sciences, Inc. announced new, long-term data from open-label extensions (OLE) of two Phase III studies (Study 1489 and Study 1490) of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir… read more.
Roche announced that the New England Journal of Medicine has published Evrysdi (risdiplam) data from the dose finding Part 1 of the pivotal FIREFISH study in infants with… read more.
Ocugen announced that its co-development partner, Bharat Biotech, announced the results of the first interim analysis of its Phase III study of Covaxin, a whole virion inactivated COVID-19… read more.
AstraZeneca and FibroGen, Inc. announced that the FDA informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new… read more.
Oncopeptides AB (publ) – announced that the FDA, has approved Pepaxto (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with… read more.
Merck announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression… read more.
BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Brukinsa (zanubrutinib) has been approved by Health Canada for the treatment of… read more.
Tricida, Inc. provided an update on its FDA interactions. Tricida has received an Appeal Denied Letter (ADL), from the Office of New Drugs (OND) of the FDA in… read more.
Pfizer announced that the FDA accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE… read more.
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