regulatory approval

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BMS gets FDA OK for first LAG-3 checkpoint inhibitor

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy, including Merck & Co.

News

Update: FDA clears first generic of AZ's blockbuster Symbico...

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca's top-selling respiratory drug Symbicort, although launch plans remain

News

AZ, Merck get FDA okay for Lynparza as adjuvant breast cance...

The FDA has cleared AstraZeneca and Merck & Co's Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown.

News

GSK’s ZEJULA gets green light for NHS use

The UK’s National Institute for Health and Care Excellence (NICE) has recommended GlaxoSmithKline’s (GSK) ZEJULA (niraparib) for some forms of ovarian, fallopian tube, and peritoneal cancer

News

FDA expands use of Abbott's heart sensor with new approval

The FDA has approved expanded labelling for Abbott's CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for

News

Ardelyx’s-ambition-to-revolutionise-kidney-treatment

EU clears Bayer's chronic kidney disease drug Kerendia

Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival th

BMS gets FDA OK for first LAG-3 checkpoint inhibitor

Update: FDA clears first generic of AZ's blockbuster Symbico...

AZ, Merck get FDA okay for Lynparza as adjuvant breast cance...

GSK’s ZEJULA gets green light for NHS use

FDA expands use of Abbott's heart sensor with new approval

EU clears Bayer's chronic kidney disease drug Kerendia

Grifols slides as Brookfield pulls out of takeover talks

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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