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European Commission approves Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma – BMS

Written by | 23 Jun 2024

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable… read more.

FDA approves expanded age indication for Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk – GSK

Written by | 22 Jun 2024

GSK plc announced that the FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50… read more.

FDA approves Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm – Almirall

Written by | 21 Jun 2024

Almirall, announced that the FDA has approved Almirall’s recent supplemental New Drug Application (sNDA) to expand the use area for its drug, Klisyri, to up to 100 cm…. read more.

European Commission authorization for Lytenava (bevacizumab gamma) for the treatment of Wet AMD – Outlook Therapeutics

Written by | 20 Jun 2024

Outlook Therapeutics, Inc., a biopharmaceutical company focused on the commercialization and development of ONs-5010/Lytenava (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, announced that the European Commission… read more.

CHMP positive recommendation for Eliquis (apixaban) to treat venous thromboembolism (VTE) and prevention of recurrent VTE in children – BMS + Pfizer

Written by | 19 Jun 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Eliquis… read more.

Elahere (mirvetuximab soravtansine) meets primary end point of PICCOLO trial in FR alpha-High, platinum-sensitive ovarian cancer – AbbVie

Written by | 18 Jun 2024

AbbVie announced positive topline results from the Phase II PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRalpha) positive, platinum-sensitive ovarian… read more.

Global experts release new guidelines on prevention of progression of epileptic seizures, addressing critical treatment gaps – UCB

Written by | 17 Jun 2024

New recommendations released in Epileptic Disorders by a global expert group comprising epileptologists, neurologists and pharmacologists from Europe and North America address the critical unmet needs associated with… read more.

New data at the European Cystic Fibrosis Conference demonstrating significant benefits of treatment with Trikafta – Vertex

Written by | 16 Jun 2024

Vertex Pharmaceuticals Incorporated announced that data on Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor,… read more.

Lorbrena (lorlatinib) CROWN study shows majority of patients with ALK-positive advanced lung cancer living beyond five years without disease progression – Pfizer

Written by | 15 Jun 2024

Pfizer Inc. announced longer-term follow-up results from the Phase III CROWN trial evaluating Lorbrena (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name Lorviqua) versus… read more.

FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors – Eli Lilly

Written by | 14 Jun 2024

The FDA has granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following: i. advanced or… read more.

Tagrisso (osimertinib) reduced the risk of disease progression or death by 84% in patients with unresectable, Stage III EGFR-mutated lung cancer vs. placebo in LAURA Phase III trial – AstraZeneca

Written by | 13 Jun 2024

Positive results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with… read more.

CE MARK for AVEIR DR, the world’s fist dual chamber leadless pacemaker system – Abbott

Written by | 12 Jun 2024

Abbott announced it has received CE Mark in Europe for the AVEIR dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacemaker that treats people… read more.

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