A convergence of regulations across life sciences has shifted quality management from a burden into an imperative for excellence.
A desire for sustainable growth is pushing gene therapy biotechs to be strategic about manufacturing and pipelines.
The EC has approved an extended use of Johnson & Johnson's Tecvayli, along with daratumumab, to treat adult patients with relapsed or refractory multiple myeloma (r/r MM).
Seralutinib is intended for the treatment of pulmonary hypertension associated with interstitial lung disease and pulmonary arterial hypertension. Credit: Green Apple/Shutterstock.com. Gossamer Bio ...
WellSpan Health and Johns Hopkins Medicine have renewed their oncology collaboration to widen access to advanced care throughout central Pennsylvania, US.
The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Eli Lilly’s Onswik (efsitora alfa) in a move that opens the insulin jab up for national ...
Kynexis will now prepare for registrational studies on lead asset, KYN-5356 in cognitive impairment associated with schizophrenia (CIAS).
Tanabe’s dersimelagon is already under FDA review having achieved positive Phase III results earlier this year.
Sandoz and Henlius will collaborate on up to 10 biosimilars amid opportunity to capitalise on global biosimilar loss-of-exclusivities.
Faeth Therapeutics has received fast track designation from the FDA for the PIKTOR with paclitaxel combination to treat advanced or recurrent endometrial cancer.
Ultragenyx Pharmaceutical has received accelerated approval from the FDA for its gene therapy, Genglycos, to treat GSDIa.
The FDA has granted accelerated approval to BMS' Zenbexus, along with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd), to treat adult multiple myeloma.
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