US FDA accepts and grants priority review status to AstraZeneca’s …
WEB2 days ago · AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The Food and Drug Administration (FDA) grants Priority Review to ...
Halozyme expands global collaboration and license agreement …
WEB1 day ago · Saturday, October 5, 2024, 11:00 Hrs [IST] Halozyme Therapeutics, Inc., a biopharmaceutical company, announced that argenx has nominated four new targets under its global collaboration and license agreement that provides argenx exclusive access to Halozyme's ENHANZE drug delivery technology, a proprietary recombinant human hyaluronidase PH20 ...
Theriva Biologics announces positive outcome of DSMC review in …
WEB1 day ago · Theriva Biologics, Inc., a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the second Cohort of its phase 1b ...
Liquidia, Pharmosa Biopharm expand collaboration to develop …
WEB2 days ago · The L606 suspension uses Pharmosa’s proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period and reducing local irritation of the upper respiratory tract. L606 is currently being evaluated in an open-label study in the United ...
US FDA grants Emergency Use Authorization to Novavax 2024 …
WEBSep 2, 2024 · US FDA grants Emergency Use Authorization to Novavax 2024-2025 Formula Covid-19 vaccine to prevent Covid-19 in individuals aged 12 and older
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US FDA grants Priority Review status Novartis’ Scemblix for …
WEBJul 31, 2024 · US FDA grants Priority Review status Novartis’ Scemblix for treatment of adults with newly diagnosed CML: East Hanover Wednesday, July 31, 2024, 12:00 Hrs [IST]
Takeda’s vedolizumab receives US FDA approval to treat …
WEBApr 20, 2024 · Osaka, Japan. Saturday, April 20, 2024, 16:00 Hrs [IST] Takeda announced that the US FDA has approved Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) Entyvio. The subcutaneous administration of …
Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
WEBFriday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...
AstraZeneca to acquire clinical-stage biopharma company, Fusion …
WEBMar 20, 2024 · AstraZeneca to acquire clinical-stage biopharma company, Fusion Pharma for $2 billion: Cambridge, UK Wednesday, March 20, 2024, 11:00 Hrs [IST] AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs).