Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo (ibalizumab-uiyk). IV push… read more.
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application… read more.
Atara Biotherapeutics, Inc. announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel or Ebvallo). Building on the earlier partnership announced in October… read more.
Santhera Pharmaceuticals announces that Agamree (vamorolone) has been approved in the European Union (EU) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age… read more.
Veoza (Veozah in the US), also known as fezolinetant, from Astellas, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) after receiving similar approval in… read more.
The FDA has approved eflornithine (Iwilfin, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least… read more.
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Biogen Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Skyclarys (omaveloxolone) for the treatment of… read more.
Arcutis Biotherapeutics, Inc. announced the FDA has approved the new drug application (NDA) for Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9… read more.
Astellas Pharma Inc. announced the European Commission (EC) on December 7 approved Veoza (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS)… read more.
Medtronic plc announced that the FDA has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This is… read more.
Detailed results from SURMOUNT-4, which showed Zepbound (tirzepatide) injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related… read more.
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