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- PMLiVE

BMS

Roche Basel Switzerland

Roche’s Tecentriq combo scores FDA approval for melanoma

Drug approved for patients with BRAF protein mutations

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- 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

Mergers and acquisitions: agents for change

Getting the best from your agency in a disruptive time

Bedrock Healthcare Communications

- 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

Roche’s Tecentriq combo scores in first-line melanoma

Plans to file treatment with health authorities on strength of data

Bristol Myers Squibb logo

BMS’ Opdivo/Yervoy combination fails to shine in melanoma

Combo therapy did not show significant benefit in key patient population

- PMLiVE

Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations

Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions

- PMLiVE

AZ’s Imfinzi combo scores in front-line lung cancer

Attempts to catch up to BMS and Merck in non-small cell lung cancer

- PMLiVE

CHMP says OK to UCB/Amgen’s Evenity for osteoporosis after appeal

Initially received a negative opinion of the drug

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