After reviewing existing published literature, the agency initiated the approval of Wellcovorin — which GSK stopped selling ...

The drug, iberdomide, is one of a few protein-degrading medicines the company hopes to become successors to its blockbuster ...

The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.

The clearance of Keytruda QLEX follows similar approvals for Bristol Myers and Roche. Elsewhere, MBX’s parathyroidism drug ...

The collapse in value of many biotechs over the past few years has created an opportunity for specialists like Xoma to “do ...

After an earlier rejection that drew criticism from some observers, the FDA quickly accepted Stealth BioTherapeutics’ new ...

The company, which is developing a competitor to Cobenfy, aims to become one of rare biotechs to price a large IPO of late.

The deal ends a short run as a publicly traded company for Metsera, which is being sold for more than double its IPO price ...

Being proactive — especially when it comes to testing, process development and preparing for commercialization — can greatly decrease the risk that your CGT will receive a CRL.

After a tumultuous two-day meeting marked by confusion and missteps, an advisory committee endorsed guidelines that would ...

Members of ACIP voted to table a planned vote on withholding some infants’ first hepatitis B vaccine dose, adding more ...

Pfizer and Arvinas plan to out-license their partnered drug vepdegestrant. Elsewhere, Novo shared more data for oral Wegovy ...