Takeda announced that, following discussions with the FDA, it will be working with the FDA towards a voluntary withdrawal of Exkivity (mobocertinib) in the U.S. for adult patients… read more.
Data from a “real world” study indicates that treatment with the semaglutide (Ozempic/Wegovy) for type 2 diabetes significantly improves both blood sugar control and weight loss for up… read more.
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe… read more.
The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent,… read more.
Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking… read more.
Seagen Inc. and Genmab A/S announced that the Phase III innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line… read more.
The EU medicines watchdog, the European Medicines Agency (EMA), has approved 14 new products at its summer meeting in Amsterdam. This brings to 46 the total number of… read more.
Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat… read more.
Roche announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA… read more.
Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for… read more.
Patients who have suffered an intracerebral hemorrhage (bleeding stroke) who subsequently take statins appear to have a lower risk of having another stroke, especially an ischemic stroke, when… read more.
A new fund to fast-track patient access to potentially valuable new medicines may incentivise the pharmaceutical industry to develop high priced drugs for rare diseases with weak evidence… read more.
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