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Valchlor

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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

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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

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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

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Pfizer’s Paxlovid receives positive opinion from CHMP

If authorised, the drug would be the first COVID-19 oral treatment recommended in the EU

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Gilead’s Trodelvy approved for triple-negative breast cancer in Europe

European patients with metastatic triple-negative breast cancer can now receive the antibody-drug conjugate as second-line monotherapy

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Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

Biogen Idec building

Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

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CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

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

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CHMP recommends eight new medicines for EU approval

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

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

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

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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

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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

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