Eli Lilly and Company and Boehringer Ingelheim’s Jardiance (empagliflozin) has obtained priority review from the US Food and Drug Administration (FDA) to treat adults with heart failure regardless of left ventricular ejection fraction (LVEF).
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s dapagliflozin as a treatment for people with chronic kidney disease (CKD).
EffRx Pharmaceuticals has received marketing authorisation from Swissmedic for Bronchitol to treat cystic fibrosis (CF) in adults and in children aged six years and above.
Novavax has completed the rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of its Covid-19 vaccine candidate, NVX-CoV2373.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine for children aged 5 to 11 years.
The European Commission (EC) has approved Merck’s Keytruda (pembrolizumab) plus chemotherapy combination to treat triple-negative breast cancer (TNBC) patients.
The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL).
The US Food and Drug Administration (FDA) has approved Oyster Point Pharma’s TYRVAYA (varenicline solution) Nasal Spray for the treatment of dry eye disease signs and symptoms.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved two additional production sites for making Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty.
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended grant of Emergency Use Authorization (EUA) for Johnson & Johnson’s (J&J) Covid-19 vaccine booster shot.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.