FDA - International Biopharmaceutical Industry

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Pfizer asks FDA to authorize COVID-19 pill

Pfizer's pill is the second oral drug for COVID-19 to be proven strongly effective in large, placebo-controlled clinical trials after Merck's molnupiravir, which earl...

19 November 2021 news clinical trials | COVID-19 pill

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Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19. Pfizer and ...

15 November 2021 news adults | BioNTech

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FibroGen cuts jobs as it weighs anemia drug’s future in US

The upcoming FDA meeting is critical for FibroGen. CEO Enrique Conterno told analysts on a conference call this week that he believes the company has a "good proposal...

15 November 2021 news anemia | AstraZeneca

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FDA extends review of J&J, Legend’s cell therapy for multiple myeloma

Abecma and cilta cel are part of an emerging class of multiple myeloma treatments that target a protein called BCMA, which is found on cancer cells. GlaxoSmithKline w...

8 November 2021 news Abecma | cell therapy

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Amylyx asks FDA to approve ALS drug, while also preparing late-stage study

Amylyx Pharmaceuticals has officially asked the Food and Drug Administration to approve its experimental and closely watched medicine for ALS. Now, the FDA has aroun...

8 November 2021 news ALS | AMX0035

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Merck wins UK authorization to sell first COVID-19 pill

U.K. regulators have once again moved faster than the Food and Drug Administration to approve a new medicine for COVID-19. The UK's Medicines and Healthcare products ...

8 November 2021 news COVID-19 | FDA

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FDA advisers support Pfizer’s coronavirus vaccine for young children

A group of advisers to the Food and Drug Administration on Tuesday endorsed use of Pfizer's coronavirus vaccine in younger children, judging the benefits of the shot ...

29 October 2021 news cases | coronavirus

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With approval plans underway, Lilly’s next move is to test its Alzheimer’s drug against Biogen’s

With few treatment options and millions of patients in the U.S. alone, Alzheimer's has long been one of the biggest targets for drug developers. Yet, the disease has...

29 October 2021 news Aduhelm | Alzheimer

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Merck agrees to license COVID-19 pill widely through pact with patent group

Merck's pill has the potential to alter the course of the pandemic. Earlier this month, the company and partner Ridgeback Biotherapeutics released data showing molnup...

29 October 2021 news COVID-19 | COVID-19 pill

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CDC panel levels playing field for new Merck, Pfizer pneumonia vaccines

This is the first time government advisers have recommended routine use of a pneumococcal vaccine for certain risk groups within the 19-64 age bracket, a move that co...

22 October 2021 news 19-64 age | Cantor Fitzgerald

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