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Flatiron

- PMLiVE

Amylyx’s Relyvrio receives FDA approval for ALS treatment

Relyvrio was shown to significantly slow physical decline in people living with ALS

- PMLiVE

Sanofi and Regeneron’s Dupixent approved by FDA for prurigo nodularis

The two phase 3 trials showed a meaningful reduction in itching

- PMLiVE

Pfizer and BioNTech seek FDA authorisation for COVID-19 booster for children

An application will also be submitted to the European Medicines Agency to extend the marketing authorisation for this age group

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Leading pharmaceutical executive Jennifer Fillman joins evidence-based solution provider Genesis Research as Chief Financial Officer

International health economics and outcomes research (HEOR) and real-world evidence (RWE) organization Genesis Research has announced the appointment of Jennifer Fillman as its new Chief Financial Officer. Prior to joining...

Genesis Research Group

- PMLiVE

Lilly’s Retevmo approved by FDA for RET fusion+ advanced/metastatic solid tumours

Results demonstrated an overall response rate of 44% across multiple tumour types

- PMLiVE

bluebird bio’s Skysona approved by FDA to treat cerebral adrenoleukodystrophy

The gene therapy was shown to slow the progression of neurologic dysfunction

- PMLiVE

FDA and NIHR launch public-private partnership for rare neurodegenerative diseases

The announcement follows President Biden signing the Accelerating Access to Critical Therapies for ALS Act in December 2021

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Genesis Research and Syapse combine forces to offer RWE and data to oncology innovators

Genesis Research is delighted to announce a strategic partnership with Syapse®, combining the expertise and resources of both companies to better serve clients that are developing new oncology innovations.

Genesis Research Group

- PMLiVE

Moderna granted FDA authorisation for emergency use of BA.4/BA.5-targeting bivalent COVID-19 booster

The application was based on preclinical data and clinical trial data available from a phase 2/3 study evaluation of the company's BA.1 Omicron-targeting bivalent booster candidate

- PMLiVE

Sanofi and Sobi’s efanesoctocog alfa granted FDA priority review for haemophilia A

Phase 3 results showed once-weekly doses provided clinically meaningful bleed protection for patients with haemophilia A

- PMLiVE

Moderna seeks FDA Emergency Use Authorisation for BA.4/BA.5 COVID-19 booster

The application is based on preclinical data and clinical trial data available from a phase 2/3 study evaluation of the company's BA.1 Omicron-targeting bivalent booster candidate

- PMLiVE

Merck granted fast track designation by FDA for end-stage renal disease therapy

MK-2060 is currently being investigated in a phase 2 study to evaluate the efficacy and safety of two different doses

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