Approvals

21 Oct 2020
- Regulation
- Approvals
Xeris Pharmaceuticals granted fast track designation by FDA for novel concentrated diazepam formulation for injection

By PBR Staff Writer

Xeris Pharmaceuticals, a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, announced it was granted fast track designation by the Food and Drug Administration (FDA) for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.
21 Oct 2020
Regulation
Approvals
Astellas Pharma gets FDA fast track status for ASP036 to treat primary mitochondrial myopathies

By PBR Staff Writer

Astellas Pharma has secured fast track status from the US Food and Drug Administration (FDA) to develop ASP0367/MA-0211 (ASP0367) as a potential treatment for primary mitochondrial myopathies (PMM).
20 Oct 2020
Regulation
Approvals
Versantis receives FDA rare paediatric disease designation for VS-01 to treat urea cycle disorders

By PBR Staff Writer

Versantis AG, a clinical-stage company developing novel therapies for orphan liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a rare pediatric disease designation (RPDD) to its lead product candidate VS-01, an ammonia clearance enhancer, for the treatment of Urea Cycle Disorders (UCD).
19 Oct 2020
Regulation
Approvals
Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukemia

By PBR Staff Writer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
16 Oct 2020
$FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL$
Regulation
Approvals
FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL

By PBR Staff Writer

Merck announced that the US Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
15 Oct 2020
Regulation
Approvals
Regeneron’s Inmazeb gets FDA approval for Ebola treatment

By PBR Staff Writer

Regeneron Pharmaceuticals’ antibody cocktail Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) has been approved by the US Food and Drug Administration (FDA) for the treatment of Zaire ebolavirus (Ebola virus).
08 Oct 2020
Regulation
Approvals
Ocular Therapeutix announces topline phase 1 clinical trial results of OTX-CSI

By PBR Staff Writer

Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced topline Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).
06 Oct 2020
Regulation
Approvals
FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease

By PBR Staff Writer

GlycoMimetics announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. This designation recognizes the significant needs in pediatric patients.
06 Oct 2020
$ImmunoGen gets FDA breakthrough therapy status for IMGN632 to treat relapsed or refractory BPDCN$
Regulation
Approvals
ImmunoGen gets FDA breakthrough therapy status for IMGN632 to treat relapsed or refractory BPDCN

By PBR Staff Writer

ImmunoGen has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its IMGN632 to treat patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
05 Oct 2020
Regulation
Approvals
FDA approves Opdivo, Yervoy combo for previously untreated unresectable MPM

By PBR Staff Writer

Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

Drug Discovery

Research & Development

FDA grants traditional approval to Novartis’ Fabhalta for IgAN

Novartis and Chai Discovery collaborate on antibody identification

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

Xeris Pharmaceuticals granted fast track designation by FDA for novel concentrated diazepam formulation for injection

Astellas Pharma gets FDA fast track status for ASP036 to treat primary mitochondrial myopathies

Versantis receives FDA rare paediatric disease designation for VS-01 to treat urea cycle disorders

Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukemia

FDA approves expanded indication for Merck’s KEYTRUDA in adult patients with relapsed or refractory cHL

Regeneron’s Inmazeb gets FDA approval for Ebola treatment

Ocular Therapeutix announces topline phase 1 clinical trial results of OTX-CSI

FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease

ImmunoGen gets FDA breakthrough therapy status for IMGN632 to treat relapsed or refractory BPDCN

FDA approves Opdivo, Yervoy combo for previously untreated unresectable MPM

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Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found