The drug, which will be sold as Qalsody by the pharmaceutical company Biogen, targets a genetic cause of a devastating neurological illness.
Category: Food and Drug Administration
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Sacklers Gave Millions to Institution That Advises on Opioid Policy
Even as the nation’s drug crisis mounted, the National Academies of Sciences, Engineering and Medicine continued to accept funds from some members of the Sackler family, including those involved with Purdue Pharma.
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Abortion Pill Maker Sues F.D.A. to Protect Drug if a Court Orders It Off the Market
The suit by GenBioPro, the generic maker of mifepristone, is the latest strand in the intense legal battle over abortion pills.
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What Bank Earnings Reveal About the Health of the Economy
JPMorgan Chase and Wells Fargo reported solid earnings on Friday, but big questions remain about the sector’s health and a potential recession.
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Earnings Season Arrives With Recession Fears Front and Center
Investors will be closely watching whether worries about an economic slowdown dent corporate profits, and lead to further layoffs.
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Appeals Court Says Abortion Pill Can Remain Available but Imposes Temporary Restrictions
The judges blocked the drug from being sent to patients through the mail and rolled back other steps the government had taken to ease access.
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Juul Reaches $462 Million Settlement With New York, California and Other States
The case ends major litigation over claims of marketing e-cigarettes to adolescents, resolving thousands of lawsuits and amounting to billions of dollars in payouts to states, cities and people.
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Why Drugmakers’ Abortion Pill Battle is Such a Big Deal
The decision by a Texas judge to overturn F.D.A. approval for the abortion pill mifepristone could upend the pharmaceutical industry.
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Pfizer CEO and Other Drug Company Leaders Condemn Texas Abortion Pill Ruling
More than 250 executives said that the decision ignored both scientific and legal precedent and, if it stands, would create uncertainty for the pharmaceutical and biotech industries.
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Abortion Ruling Could Undermine the F.D.A.’s Drug-Approval Authority
Legal scholars say the ruling by a Texas judge, if upheld, could spur disputes over many medications and upend the drug industry’s reliance on the agency.
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What’s Going On With the Abortion Pill Rulings by Federal Judges?
One invalidated the F.D.A.’s approval of the abortion pill mifepristone. The other ordered the F.D.A. to do nothing to restrict the pill’s availability.
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Texas Judge Invalidates FDA Approval of the Abortion Pill Mifepristone
The Texas judge’s ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available.