Regulation

24 Aug 2020
- Regulation
- Approvals
FDA issues EUA for convalescent plasma as potential promising Covid–19 treatment

By PBR Staff Writer

The US Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.
21 Aug 2020
Regulation
Approvals
Novartis gets FDA nod for Kesimpta to treat relapsing multiple sclerosis

By PBR Staff Writer

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kesimpta (ofatumumab) to treat relapsing forms of multiple sclerosis (RMS).
19 Aug 2020
Regulation
Drug Filing
Imfinzi granted FDA priority review for less-frequent, fixed-dose use

By PBR Staff Writer

AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
17 Aug 2020
Drug Discovery
Research & Development
Clinical Trials
New Edition of NSF’s Health Sciences Journal Now Live

By victoria.smith

This edition of the health sciences Journal is about hope and optimism, and how we must rethink our ways of working.
17 Aug 2020
Regulation
Approvals
Chugai’s Enspryng receives regulatory approval from FDA for neuromyelitis optica spectrum disorder

By PBR Staff Writer

Chugai Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has approved the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody, Enspryng (US generic name: satralizumab-mwge) (hereafter, Enspryng) created by Chugai for the treatment of adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
11 Aug 2020
Regulation
Drug Filing
Gilead seeks FDA approval for Veklury in Covid-19 treatment

By PBR Staff Writer

Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) seeking its approval for the treatment of Covid-19.
10 Aug 2020
Regulation
Approvals
US FDA approves Lampit for the treatment of Chagas disease in children

By PBR Staff Writer

Bayer announced that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi).
10 Aug 2020
Regulation
Approvals
Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy

By PBR Staff Writer

Roche has secured approval from the US Food and Drug Administration (FDA) for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in adults and children aged two months of age and older.
07 Aug 2020
Regulation
Approvals
ViiV Healthcare gets FDA expanded approval for HIV-1 drug Dovato

By PBR Staff Writer

Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) as a complete regimen to treat HIV-1 infection.
06 Aug 2020
$GSK secures FDA nod for BLENREP to treat relapsed or refractory multiple myeloma$
Regulation
Approvals
GSK secures FDA nod for BLENREP to treat relapsed or refractory multiple myeloma

By PBR Staff Writer

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its BLENREP (belantamab mafodotin-blmf) to treat patients with relapsed or refractory multiple myeloma.

Drug Discovery

Research & Development

Pfizer and Innovent Biologics sign $10.5bn cancer drug development deal

SK bioscience and VECOL partner on Colombia vaccine manufacturing initiative

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Gerresheimer at CPHI Frankfurt 2025

Gerresheimer

Suppliers

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Regulation

FDA issues EUA for convalescent plasma as potential promising Covid–19 treatment

Novartis gets FDA nod for Kesimpta to treat relapsing multiple sclerosis

Imfinzi granted FDA priority review for less-frequent, fixed-dose use

New Edition of NSF’s Health Sciences Journal Now Live

Chugai’s Enspryng receives regulatory approval from FDA for neuromyelitis optica spectrum disorder

Gilead seeks FDA approval for Veklury in Covid-19 treatment

US FDA approves Lampit for the treatment of Chagas disease in children

Roche gets FDA nod for Evrysdi to treat spinal muscular atrophy

ViiV Healthcare gets FDA expanded approval for HIV-1 drug Dovato

GSK secures FDA nod for BLENREP to treat relapsed or refractory multiple myeloma

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

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