MSD (Merck & Co) has won US Food and Drug Administration (FDA) approval for its cholesterol-lowering pill, marking a significant milestone in the drugmaker’s push to reduce revenue reliance on ...

The FDA has issued traditional approval to Novartis for Fabhalta to slow the decline of kidney function in adults with primary IgAN who are at risk of disease progression.

The US Food and Drug Administration (FDA) has approved two of Merck & Co’s (MSD) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev ...

The proposed rule would allow multiple manufacturing units at different locations to register as one establishment.

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended a routine programme with the 4CMenB vaccine for adolescents.

Harbour BioMed and Kelun-Biotech have received approval from China’s NMPA for their IND application for the HBM7575/SKB575 bispecific antibody intended to treat asthma.

Blood-based biomarkers could play a key role in detecting and treating Alzheimer’s early at the first point of contact, experts say.

Bayer's Kerendia will become available to English patients with chronic heart failure with preserved or mildly reduced ejection fraction.

In licensing Zegfrovy, AstraZeneca has gained an already approved asset, with a label expansion potentially on the horizon.

Novo Nordisk is continuing to maintain its advantage in the obesity pill race after winning European approval for oral Wegovy (semaglutide). The European Commission (EC) granted m ...

There are a range of cost-containment measures across the bill that will create a significant healthcare system shakeup.

Cellares and Sonoma Biotherapeutics have partnered to automate the manufacturing of the latter’s SBT-77-7101 programme using the Cellares Cell Shuttle platform.