Pfizer and its partner BioNTech are seeking approval from the US Food and Drug Administration (FDA) for their booster dose of Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.
The European Commission (EC) has approved AbbVie's Rinvoq (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who are candidates for systemic therapy.
The US Food and Drug Administration (FDA) has fully approved Pfizer and BioNTech’s biologics license application (BLA) for their Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.
The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Zydus Cadila’s ZyCoV-D Covid-19 vaccine for adolescents aged 12 years and above.
The European Commission (EC) has given conditional marketing authorization (CMA) to Bristol Myers Squibb’s (BMS) CAR T-cell therapy Abecma (idecabtagene vicleucel; ide-cel).
The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly and Company’s Jardiance (empagliflozin) to treat Heart Failure with reduced Ejection Fraction (HFrEF).
Pfizer and its partner BioNTech have submitted the initial data of an early-stage trial to the US Food and Drug Administration (FDA) to support the authorisation of a booster dose of their Covid-19 vaccine.
Merck, called MSD outside the US and Canada, has initiated a rolling submission to Health Canada for molnupiravir, an investigational oral antiviral therapy for the treatment of Covid-19.
The US Food and Drug Administration (FDA) has authorised additional doses of Pfizer-BioNTech and Moderna Covid-19 vaccines for certain people with compromised immune systems.
The US Food and Drug Administration (FDA) has declined to approve AstraZeneca and FibroGen’s new drug application (NDA) for roxadustat to treat anaemia associated with chronic kidney disease (CKD).
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.