Medical Regulatory Issues

Government experts urge new talc testing standards amid asbestos worries

Government experts urge new talc testing standards amid asbestos worries

Published 11/01/2020

(Reuters) - An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions [more…]

Merck’s Keytruda wins U.S. FDA approval for bladder cancer

Merck’s Keytruda wins U.S. FDA approval for bladder cancer

Published 08/01/2020

(Reuters) - The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co Inc’s Keytruda for a hard-to-treat form of bladder cancer, [more…]

Eisai Inc announces U.S. approval for insomnia drug

Eisai Inc announces U.S. approval for insomnia drug

Published 22/12/2019

(Reuters) - Japan-based drugmaker Eisai Co’s U.S. subsidiary announced on Sunday that it had received approval from the U.S. Food and Drug Administration for its [more…]

Israel’s IceCure says gets FDA nod to treat tumors in liver, kidney

Israel’s IceCure says gets FDA nod to treat tumors in liver, kidney

Published 22/12/2019

JERUSALEM (Reuters) - Israel’s IceCure Medical said on Sunday it received U.S. regulatory approval to expand the use of its cryoablation technology to treat benign [more…]

U.S. FDA declines to approve GSK drugs division’s long acting HIV injection

U.S. FDA declines to approve GSK drugs division’s long acting HIV injection

Published 21/12/2019

(Reuters) - GlaxoSmithKline’s HIV drugs division ViiV Healthcare said on Saturday that the U.S. Food and Drug Administration declined to approve its long acting HIV [more…]

Merck says Ebola vaccine to be available at lowest access price for poor nations

Merck says Ebola vaccine to be available at lowest access price for poor nations

Published 20/12/2019

(Reuters) - Merck & Co (MRK.N) said on Friday it expects to make licensed doses of its recently approved Ebola vaccine available in the third [more…]

AstraZeneca, Daiichi’s breast cancer drug gets accelerated approval from FDA

AstraZeneca, Daiichi’s breast cancer drug gets accelerated approval from FDA

Published 20/12/2019

(Reuters) - The U.S. Food and Drug Administration said on Friday it had approved Daiichi Sankyo Co Ltd and AstraZeneca Plc’s drug to treat an [more…]

Sarepta shares surge after surprise approval of Duchenne Muscular Dystrophy drug

Sarepta shares surge after surprise approval of Duchenne Muscular Dystrophy drug

Published 13/12/2019

(Reuters) - Shares of Sarepta Therapeutics Inc (SRPT.O) soared 31% on Friday after U.S. regulators shocked Wall Street by approving the company’s treatment for a [more…]

FDA panel votes unanimously in favor of Horizon’s thyroid eye disease drug

FDA panel votes unanimously in favor of Horizon’s thyroid eye disease drug

Published 13/12/2019

(Reuters) - Independent advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of Horizon Therapeutics Plc’s experimental treatment for active [more…]

FDA says Amarin can market fish-oil derived therapy for reducing heart attack risk

FDA says Amarin can market fish-oil derived therapy for reducing heart attack risk

Published 13/12/2019

(Reuters) - U.S. health regulators on Friday approved expanding the heart benefit claims Amarin Corp can make in promoting its drug Vascepa to include reducing [more…]