FDA - International Biopharmaceutical Industry

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

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

Continue Reading →

news

Lilly drug cleared by FDA for wider use in breast cancer

The new label opens up a significant market opportunity for Lilly, as about 70% of people diagnosed with breast cancer have the hormone receptor positive, HER-2 negat...

15 October 2021 news breast cancer | FDA

Continue Reading →

news

Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

Merck's Keytruda is the dominant cancer immunotherapy and, of the seven of its type that are approved, the only that's cleared for use in cervical cancer, the fourth ...

15 October 2021 news cervical cancer | clinical trial

Continue Reading →

news

J&J asks FDA to clear booster dose of its coronavirus vaccine

For the past several months, one of the many questions hanging over the booster debate has ben what do with people who got J&J's shot. The company's application, ...

8 October 2021 news Centers of Disease Control and Prevention | coronavirus vaccine

Continue Reading →

Current Edition

Upcoming Events

Advertisement

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

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

Merck wins UK authorization to sell first COVID-19 pill

FDA advisers support Pfizer’s coronavirus vaccine for young children

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

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

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

Lilly drug cleared by FDA for wider use in breast cancer

Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

J&J asks FDA to clear booster dose of its coronavirus vaccine

International Biopharmaceutical Industry