Pharmaceutical Industry news, analysis and insights
The latest news from the global pharmaceutical industry
The WHO has shared a medical product alert for an additional contaminated cough syrup medicine identified in Africa.
Astellas Pharma and Mitsui Fudosan have announced that Astellas plans to establish a tumour microenvironment (TME) open innovation hub, intended to open in October 2023.
GSK has announced that the FDA has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (DMMR) or microsatellite instability-high (MSI-H).
Japanese Eisai and US-based biotechnology company Biogen have announced that the FDA has given their Alzheimer’s disease drug Leqembi (lecanemab-irmb) full approval through the approval of a supplemental biologics license application.
FDA has announced that it has approved the Opill (norgestrel) tablet for non-prescription use to prevent pregnancy.
The FDA has announced that it has approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adult patients with type 1 diabetes.
The US Food and Drug Administration (FDA) has announced that it has approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of adult patients with mild-to-moderate COVID-19 if they are at high risk for progression to severe COVID-19, including hospitalisation or death.
The US Food and Drug Administration (FDA) has released updated guidance for blood donation, which relaxes the rules for donations from men who have sex with men (MSM).
The US centers for disease control and prevention (CDC) have released updated data regarding contaminated eyedrops. As of may 2023, 81 patients in 18 states have tested positive for VIM-GES-CRPA, a rare strain of drug-resistant pseudomonas aeruginosa.
GSK has announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (SBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (DMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 60 years or older.
Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its new drug application (NDA) has been accepted by the US Food and Drug Administration (FDA) for its ros1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) treatment repotrectinib.