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- PMLiVE

Revinty Ellipta

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- PMLiVE

EMA to support real-world monitoring of COVID-19 treatments/vaccines

New infrastructure will support real-world studies

- PMLiVE

In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa

Monthly meeting held remotely for the first time due to COVID-19 pandemic

- PMLiVE

FDA says no to Lilly, Boehringer’s Jardiance in type 1 diabetes

Formally rejects extended use of SGLT2 inhibitor

- PMLiVE

EMA calls for pooled EU research into COVID-19 therapies

Asks for a harmonised methodology across member states

EU flag

EMA to consider coronavirus’ impact on EU medicines supply

Steering group will identify EU-wide actions to mitigate medicine supply risks

- PMLiVE

Modest meeting sees only two drugs recommended by CHMP

Lilly’s migraine med Emgality receives negative opinion for label extension

- PMLiVE

Givlaari, Rybelsus lead crowded CHMP recommendations

EU regulator delivered 15 positive opinions and no rejections

Bristol Myers Squibb logo

Another blow for BMS in first-line NSCLC as it pulls EU filing

Opdivo/Yervoy combination is still under review with the FDA

- PMLiVE

It’s Brexit day – now comes the really hard stuff

Months of trade negotiations between UK and EU lie ahead

- PMLiVE

Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

Roche Basel Switzerland

EMA backs adjuvant use of Roche’s breast cancer ADC Kadcyla

Could face tough competition soon from a number of rivals

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