FDA - International Biopharmaceutical Industry

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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

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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

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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

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As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

The FDA has been under pressure to review the status of drugs granted accelerated approvals based on early data, as in some cases confirmatory trials haven't been com...

30 September 2021 news AstraZeneca | Bristol Myers Squibb

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FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy

While the clinical hold lifting is encouraging news for the companies' partnership, questions still loom about safety in the genetic medicine field. Earlier this mont...

30 September 2021 news Angelman | FDA

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Top FDA official takes over vaccine office as agency weighs COVID-19 shots for kids

Peter Marks, one of the Food and Drug Administration's top-ranking officials, has taken over the agency's vaccine review office just as the regulator begins consideri...

30 September 2021 news BioCentury | COVID-19

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Takeda wins FDA approval for targeted lung cancer drug

In the midst of a years-long makeover, Takeda is looking to new products such as Exkivity to shore up future growth and cement its place as a major player in the phar...

17 September 2021 news FDA | lung cancer

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Galapagos CEO to retire, though successor yet to be announced

Galapagos looked to be in a strong position at the start of 2020. It had recently closed a major research deal with Gilead that not only provided substantial amounts ...

3 September 2021 news drug development | FDA

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FDA grants full approval to Pfizer, BioNTech’s coronavirus vaccine

The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech's coronavirus vaccine, a long-awaited decision that government officials hope ...

27 August 2021 news BioNTech | coronavirus vaccine

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AstraZeneca reports study success for rare disease drug acquired in Alexion deal

Should detailed study results bear out ALXN1480's benefit and lead to an FDA approval, the experimental drug could become an important new option for people with Wils...

27 August 2021 news Alexion | ALXN1480

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