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

Sivextro

- PMLiVE

AstraZeneca receives CHMP recommendations for Imfinzi, Enhertu and Lynparza

The treatments are for use in prostate, biliary tract and advanced gastric cancer

- PMLiVE

Sanofi/Regeneron’s Dupixent receives CHMP recommendation for prurigo nodularis

Two phase 3 trials showed a reduction in itch, skin lesions and health-related quality of life

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation for children five to 11 years

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

GSK to submit drug application for new antibiotic to US FDA

Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

- PMLiVE

Merck and Bill & Melinda Gates Institute sign licensing agreement for tuberculosis candidates

The non-profit will determine their potential for inclusion in new affordable treatment regimens

- PMLiVE

Takeda’s dengue vaccine candidate recommended for approval by CHMP

Dengue disease causes around 390 million infections and 500,000 hospitalisations each year

- PMLiVE

Novartis bags CHMP recommendation for prostate cancer drug Pluvicto

The recommendation is for use in combination with androgen deprivation therapy

- PMLiVE

BeiGene’s Brukinsa receives CHMP recommendation for chronic lymphocytic leukaemia

CLL accounts for around one-quarter of new leukaemia cases

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

- PMLiVE

Bristol Myers Squibb’s Opdualag approved by CHMP for melanoma

If approved by the EC, Opdualag would be the first LAG-3 blocking antibody combination available in Europe

- PMLiVE

AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

- PMLiVE

Gilead’s COVID-19 drug Veklury recommends for approval by CHMP

If approved by the EC, Veklury will become the only direct-acting antiviral with full marketing authorisation in the EU

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links