Approvals

08 May 2019
- Regulation
- Approvals
European Commission approves LORVIQU for certain adult patients with previously-treated ALK-positive NSCLC

By PBR Staff Writer

Pfizer announced that the European Commission (EC) granted conditional marketing authorization for LORVIQUA (lorlatinib, available in the US, Canada and Japan under the brand name LORBRENA), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI. LORVIQUA is a third-generation ALK TKI that was specifically developed to penetrate the blood brain barrier, in the presence or absence of resistance mutations.
08 May 2019
Regulation
Approvals
Roche’s Kadcyla gets FDA nod for adjuvant treatment of HER2+ early breast cancer

By PBR Staff Writer

Roche has secured approval from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) Kadcyla (trastuzumab emtansine) for the adjuvant treatment of HER2-positive early breast cancer in certain patient population.
07 May 2019
Regulation
Approvals
Pfizer gets FDA nod for Vyndaqel and Vyndamax to treat transthyretin amyloid cardiomyopathy

By PBR Staff Writer

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) to treat patients with transthyretin amyloid cardiomyopathy.
06 May 2019
Regulation
Approvals
Qternmet XR approved in US for treatment of type-2 diabetes

By PBR Staff Writer

The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).
02 May 2019
Regulation
Approvals
Sanofi Pasteur gets FDA approval for Dengvaxia vaccine to prevent dengue disease

By PBR Staff Writer

Sanofi Pasteur has secured approval from the US Food and Drug Administration (FDA) for its Dengvaxia vaccine for the prevention of dengue disease in endemic regions.
01 May 2019
Regulation
Approvals
FDA approves KALYDECO for treatment of eligible infants with cystic fibrosis

By PBR Staff Writer

Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO (ivacaftor) for use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.
30 Apr 2019
Regulation
Approvals
Finch Therapeutics receives fast track designation for investigation of Full-Spectrum Microbiota as treatment for children with autism spectrum disorder

By PBR Staff Writer

Finch Therapeutics Group announced that the US Food and Drug Administration (FDA) has granted fast track designation to its Full-Spectrum Microbiota (FSM) therapy for the treatment of children with Autism Spectrum Disorder (ASD).
29 Apr 2019
Regulation
Approvals
GSK gets FDA nod for Benlysta to treat pediatric patients with lupus

By PBR Staff Writer

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE).
25 Apr 2019
Regulation
Approvals
Knopp Biosciences gets FDA orphan drug designation for dexpramipexole tp treat hypereosinophilic syndrome

By PBR Staff Writer

Knopp Biosciences announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES).
23 Apr 2019
Regulation
Approvals
FDA approves Merck’s Keytruda plus Inlyta to treat advanced renal cell carcinoma

By PBR Staff Writer

Merck has secured approval from the US Food and Drug Administration (FDA) for Keytruda in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Drug Discovery

Research & Development

SciNeuro and Novartis sign global licensing deal for Alzheimer’s antibody

Atara receives FDA complete response letter for Ebvallo BLA application

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

No data found

Approvals

European Commission approves LORVIQU for certain adult patients with previously-treated ALK-positive NSCLC

Roche’s Kadcyla gets FDA nod for adjuvant treatment of HER2+ early breast cancer

Pfizer gets FDA nod for Vyndaqel and Vyndamax to treat transthyretin amyloid cardiomyopathy

Qternmet XR approved in US for treatment of type-2 diabetes

Sanofi Pasteur gets FDA approval for Dengvaxia vaccine to prevent dengue disease

FDA approves KALYDECO for treatment of eligible infants with cystic fibrosis

Finch Therapeutics receives fast track designation for investigation of Full-Spectrum Microbiota as treatment for children with autism spectrum disorder

GSK gets FDA nod for Benlysta to treat pediatric patients with lupus

Knopp Biosciences gets FDA orphan drug designation for dexpramipexole tp treat hypereosinophilic syndrome

FDA approves Merck’s Keytruda plus Inlyta to treat advanced renal cell carcinoma

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found