Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Gamifant

- PMLiVE

CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

Results of eight main studies of drug were 'inconsistent', according to the CHMP

- PMLiVE

EMA begins rolling review of Sanofi, GSK’s COVID-19 vaccine

Rolling review launched based on preliminary results from lab studies and early clinical studies

- PMLiVE

bluebird bio to restart marketing of Zynteglo in EU after previous suspension

EMA’s safety committee PRAC has confirmed favourable risk-benefit balance of gene therapy

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

- PMLiVE

bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

- PMLiVE

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine

Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets

- PMLiVE

J&J delays EU COVID-19 vaccine rollout following pause in the US

FDA and CDC recommended pausing rollout in US after reported cases of rare blood clots in vaccinated individuals

- PMLiVE

New restrictions for AZ/Oxford COVID-19 vaccine despite EMA endorsement

Regulators in Canada and Germany have reportedly placed new restrictions on vaccine

- PMLiVE

EMA recommends new manufacturing sites for COVID-19 vaccines

EMA also recommends new storage temperature for Pfizer/BioNTech vaccine

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

- PMLiVE

EMA updates product information for AZ COVID-19 vaccine

PRAC reaffirms opinion that AZ vaccine's efficacy outweighs very rare likelihood of developing a blood clotting disorder

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links