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Longer term results from phase III ASC4FIRST trial with Scemblix (asciminib) showing superior major molecular response rates at week 96 – Novartis

Written by | 16 Dec 2024

Novartis announced positive, longer-term results from the pivotal Phase III ASC4FIRST trial with Scemblix (asciminib) showing superior major molecular response (MMR) rates at week 96 . The study… read more.

FDA approves Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa – UCB

Written by | 15 Dec 2024

UCB,  announced that the FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved… read more.

FDA accepts supplemental BLA for Columvi (glofitamab) + chemotherapy combination for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Written by | 14 Dec 2024

Roche announced the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people… read more.

European Commission approves Kisqali (ribociclib) with an aromatase inhibitor for the adjuvant treatment of HR-positive, HER2-negative early breast cancer – Novartis

Written by | 13 Dec 2024

 Novartis announced that  the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive,… read more.

European Commisson approves Elahere (mirvetuximab soravtansine) for FRα positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer – Abbvie

Written by | 12 Dec 2024

AbbVie  announced the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous… read more.

Positive results from phase III ZENITH study of Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension – Merck Inc

Written by | 11 Dec 2024

Merck Inc.,( known as MSD outside of the United States and Canada), announced  positive topline results from the Phase III ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with… read more.

MHRA (UK) approves cream for the treatment of adult patients with moderate to severe chronic hand eczema – Leo Pharma

Written by | 10 Dec 2024

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for LEO Pharma’s Anzupgo (delgocitinib) cream for the treatment of adult patients with moderate to severe… read more.

Coherus BioSciences sells Udenyca franchise to Intas Pharmaceuticals

Written by | 9 Dec 2024

Coherus BioSciences, Inc.  announced that it has entered into an asset purchase agreement  dated December 2, 2024, with Intas Pharmaceuticals Ltd.  for the divestiture of the Udenyca  (pegfilgrastim-cbqv)… read more.

First single-dose medicine for P. vivax malaria prequalified by WHO and included in WHO Guidelines – GSK

Written by | 8 Dec 2024

GSK plc and Medicines for Malaria Venture (MMV) announced that the World Health Organization (WHO) has awarded prequalification to tafenoquine, the first single-dose medicine for the prevention of… read more.

FDA approves Yesintek, a biosimilar to the reference product, Stelara – Biocon Biologics

Written by | 7 Dec 2024

Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced  that the FDA  has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference… read more.

FDA Premarket Approval Application Supplement approved for the Oxford Cementless Partial Knee – Zimmer Biomet

Written by | 6 Dec 2024

Zimmer Biomet Holdings, Inc. announced FDA Premarket Approval Application (PMA) Supplement approval for the Oxford Cementless Partial Knee. The approval is based on safety and effectiveness data from… read more.

FDA investigation of blood cancer risk from Skysona (elivaldogene autotemcel) – Bluebird Bio

Written by | 5 Dec 2024

The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona   (elivaldogene autotemcel) and is evaluating the need for “further regulatory… read more.

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