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- PMLiVE

US COVID-19 booster programme expanded

The FDA and CDC have given the green light to an expansion of the US COVID-19 booster programme to include another shot of the Moderna and J&J vaccines as well...

- PMLiVE

The FDA vaccine advisory board recommends booster shots of both the J&J and Moderna vaccines

J&J’s data showed that a second shot of its vaccine boosts protection to 94% against symptomatic moderate-to-severe infection when administered two months after the first dose

- PMLiVE

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

- PMLiVE

NICE recommends Novartis’ Adakveo for sickle cell disease

The treatment for sickle cell disease is the first in more than 20 years

- PMLiVE

Janssen’s RSV vaccine provides high protection against respiratory infections

The phase 2b data showed the RSV vaccine provided 80% protection against lower respiratory infections in adults aged 65 and older

- PMLiVE

Strong five-year survival data for Kisqali in breast cancer

Novartis’ Kisqali plus letrozole offers more than a year survival benefit for postmenopausal women with HR+/HER2 advanced breast cancer

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

- PMLiVE

UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients

The approval for the Novartis drug by the NHS gatekeeper could save 30,000 lives over 10 years

- PMLiVE

NICE recommends Novartis’ Rydapt for advanced SM treatment

The twice-daily, oral drug improves overall survival of people with the rare blood disorder

- PMLiVE

EC approves BMS cell therapy for multiple myeloma

The approval of Abecma is based on “rapid, deep and durable” trial responses

- PMLiVE

FDA grants orphan drug status to Allogene’s BCMA-targeted treatment for multiple myeloma

The decision follows the RMAT designation granted by the FDA in April

- PMLiVE

J&J and Pfizer quietly resolve Remicade biosimilar lawsuit

In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a bid to protect Remicade

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