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The FDA has approved Onyda XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD – Tris Pharma

Written by | 6 Jun 2024

Tris Pharma, Inc., a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced the FDA has approved Onyda XR (clonidine hydrochloride),… read more.

CHMP positive opinion for two 320 mg device presentations of Bimzelx (bimekizumab) – UCB

Written by | 5 Jun 2024

UCB, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting marketing authorization for… read more.

CHMP positive recommendation for Ixchiq a Chikungunya vaccine – Valneva SE

Written by | 4 Jun 2024

Valneva SE a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion… read more.

FDA approves Bkemv the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases – Amgen

Written by | 3 Jun 2024

The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are… read more.

European Commission returns Translarna Opinion to CHMP for re-evaluation – PTC Therapeutics

Written by | 2 Jun 2024

PTC Therapeutics, Inc. announced that the European Commission (EC) has decided not to adopt the CHMP’s negative opinion of January 24, 2024 on the annual renewal of the… read more.

FDA approves ColoSense – a noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test – Geneoscopy Inc

Written by | 1 Jun 2024

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that the FDA approved its noninvasive colorectal cancer screening test,… read more.

Affera Mapping and Ablation System with Sphere-9 catheter achieves endpoints for safety and efficacy, providing promising evidence for the future of atrial fibrillation treatment – Medtronic

Written by | 31 May 2024

Medtronic plc , announced positive results demonstrating excellent safety and efficacy of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one pulsed field (PF) and radiofrequency… read more.

European Commission approves Wyost (denosumab) and Jubbonti (denosumab) which are the first and only biosimilars of denosumab in Europe – Sandoz

Written by | 30 May 2024

Sandoz, the global leader in generic and biosimilar medicines, announced that the European Commission (EC) has granted marketing authorization for Wyost (C) and Jubbonti (denosumab), the first and… read more.

Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm

Written by | 29 May 2024

Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to Humira (adalimumab), in the… read more.

Breyanzi (lisocabtagene maraleucel) approved by the FDA for relapsed or refractory follicular lymphoma – BMS

Written by | 28 May 2024

Bristol Myers Squibb announced the FDA has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of… read more.

Eisai initiates rolling biologics license application to FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the Fast Track status

Written by | 27 May 2024

-Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name:Leqembi)… read more.

Approval of Augtyro (repotrectinib) for patients with ROS1-positive NSCLC by China’s NMPA – Zai Lab

Written by | 26 May 2024

Zai Lab Limited announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for Augtyro (repotrectinib) for the treatment of adult… read more.

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