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Harmony Biosciences, LLC, a private biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult...
FDA approves novel device to treat symptoms associated with advanced heart failure
The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices...
Roche’s Rozlytrek receives US FDA approval to treat people with NTRK gene fusion─positive solid tumours
Roche announced that the US Food and Drug Administration (FDA) has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1─positive, metastatic non─small cell lung cancer (NSCLC).
FDA approves first spinal tether device to treat children with idiopathic scoliosis
The U.S. Food and Drug Administration today approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis, that has not...
EMA/US FDA analysis shows high degree of alignment in marketing application decisions between EU & US
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are aligned in more than 90 per cent of marketing authorisation decisions for new medicines.
US FDA approves AbbVie’s oral JAK inhibitor, Rinvoq to treat rheumatoid arthritis
AbbVie, a research─based global bio pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), a 15 mg, once─daily oral Janus kinase (JAK) inhibitor, for the...
Celgene’s Inrebic becomes second FDA-approved therapy for rare bone marrow disorder
Celgene is celebrating the approval in the US of its Janus kinase (JAK) 2 inhibitor Inrebic (fedratinib) in the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis, a rare disorder of the bone...
Lilly’s Taltz beats Janssen’s Tremfya at Phase 4 in plaque psoriasis
Eli Lilly has unveiled new Phase 4 data supporting the efficacy and safety of Taltz (ixekizumab) when compared to Janssen’s Tremfya (guselkumab), showing that the former met all primary and secondary endpoints in the...
Janssen chalks up two more indications in Europe for Imbruvica combo therapies
Janssen’s has secured a label expansion from the European Commission for its Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), approving the therapy in two new indications. The ruling authorises...
Viermaal groen licht voor geneesmiddelen
De Committee for Medicinal Products for Human Use (CHMP) heeft een positief advies gegeven over nieuwe handelsvergunningen voor vier geneesmiddelen.
FDA approved new drug for treatment-resistant TB
The US FDA has approved BPaL, the TB Alliance’s treatment for drug-resistant tuberculosis (TB). The US regulator gave the go-ahead to the TB Allliance’s Pretomanid Tablets as part of a three drug combo, as a treatment...
Social media: dé trends & tips voor de tweede helft van 2019
Ben jij opgeladen en weer klaar om aan de slag te gaan na je vakantie? Start de (gevoelsmatig) tweede helft van je jaar goed en lees dit artikel over social media. Zo ben je helemaal op de hoogte en kun je met een...
13 Easy Tips to Give Your Content More Personality
Creating content that attracts an audience – and keeps them reading and connected to your brand’s content – can be a challenge. To make your next pieces shinier, here are 13 easy tips to pack more personality into your...
Meet jij wel het échte engagement op je content?
Wanneer ben jij tevreden met je content? Het lijkt heel mooi als een artikel veel views haalt en dus veel mensen bereikt. Maar is dat ook je doel met je content? Content Marketing Institute (CMI) laat drie fouten zien...
Eli Lilly scores positive phase 3 results for Emgality in treatment resistant migraine
Hopes to catch up with rivals in the market
Evofem announces additional data from phase 3 ‘AMPOWER’ study of Amphora for hormone─free birth control
Evofem Biosciences, a clinical─stage biopharmaceutical company, reported additional data from its phase 3 ‘AMPOWER’ clinical trial of Amphora for the prevention of pregnancy. These findings reveal that the
Roche’s Tecentriq meets primary endpoint in Phase 3 bladder cancer trial
Roche has said its immunotherapy drug Tecentriq (Atezolizumab), when used in combination with platinum-based chemotherapy, significantly reduced the risk of disease worsening and death in a Phase 3 trial of patients...
Astellas begins phase 3 trials of fezolinetant in postmenopausal women with vasomotor symptoms
Astellas Pharma Inc announced dosing of the first patient in the SKYLIGHT 1 phase 3 pivotal trial for fezolinetant, an investigational oral, non─hormonal compound being studied for the treatment of moderate─to─severe...
