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2959 News Found

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU


Takeda receives positive CHMP opinion for Fruquintinib in previously treated mCRC
Drug Approval | April 27, 2024

Takeda receives positive CHMP opinion for Fruquintinib in previously treated mCRC

If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings
Drug Approval | April 23, 2024

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients


Bristol Myers Squibb and Cellares inks US$ 380 million capacity reservation for the manufacture of CAR T Cell Therapies
News | April 23, 2024

Bristol Myers Squibb and Cellares inks US$ 380 million capacity reservation for the manufacture of CAR T Cell Therapies

Cellares will dedicate multiple Cell Shuttle and Cell Q systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue


Biocon receives approval from SAHPRA for Tacrolimus Capsule
News | April 22, 2024

Biocon receives approval from SAHPRA for Tacrolimus Capsule

Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients


Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA
Drug Approval | April 22, 2024

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A


Evotech and Variant Bio partner to develop fibrosis treatment
News | April 22, 2024

Evotech and Variant Bio partner to develop fibrosis treatment

Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program


Zydus launches Mirabegron ER Tablets in the US
Drug Approval | April 22, 2024

Zydus launches Mirabegron ER Tablets in the US

Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market