FDA Authorizes Pfizer-BioNTech Vaccine for Emergency Use in Adolescents
Health
FDA Authorizes Pfizer-BioNTech Vaccine for Emergency Use in Adolescents
2021-05-11 15:48:23
by Alexa Hornbeck

WASHINGTON - The U.S. Food and Drug Administration announced Monday the Pfizer-BioNTech vaccine has been approved for emergency use for adolescents ages 12 to 15 years of age.  “Parents and guardians can rest assured that the agency undertook a rigorous... Read More

FDA Expected to OK Pfizer Vaccine for Teens Within Week
Health
FDA Expected to OK Pfizer Vaccine for Teens Within Week

WASHINGTON (AP) — The U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots... Read More

Alarming Lapses in Inspection of Drugs Made in Foreign Countries
Prescription Drugs
Alarming Lapses in Inspection of Drugs Made in Foreign Countries
2021-03-10 14:33:10
by Tom Ramstack

WASHINGTON -- A government report released Tuesday raised alarms about the quality of pharmaceuticals made in foreign countries but consumed by Americans. It said the purity of the drugs is questionable because of a lack of adequate inspections by the... Read More

FDA Clears Single-Shot Vaccine for Use
Health
FDA Clears Single-Shot Vaccine for Use
2021-03-01 19:32:41
by Daniel Mollenkamp

WASHINGTON - On Saturday, the Food and Drug Administration gave emergency authorization to a third coronavirus vaccine. This vaccine, unlike the Pfizer and Moderna vaccines which received emergency authorizations in December, is a single shot vaccine.  Placebo-controlled, randomized studies of... Read More

FDA Relaxes Vaccine Storage Rules to Speed Up Rollout
Health
FDA Relaxes Vaccine Storage Rules to Speed Up Rollout
2021-02-26 21:31:46
by Daniel Mollenkamp

WASHINGTON - The Food and Drug Administration has relaxed the rules around storage and transportation for some coronavirus vaccines in order to speed up the vaccine rollout. Frozen vials of Pfizer-BioNTech's coronavirus vaccine will be allowed to be kept at... Read More

FDA Says J&J 1-Dose Shot Prevents COVID; Final Decision Soon
Health
FDA Says J&J 1-Dose Shot Prevents COVID; Final Decision Soon

WASHINGTON (AP) — Johnson & Johnson's single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.  The Food... Read More

FDA Greenlights Record Number of Medical Devices
Health
FDA Greenlights Record Number of Medical Devices
2021-02-18 20:18:43
by Daniel Mollenkamp

WASHINGTON - In a public health milestone, the Food and Drug Administration announced on Tuesday that it approved a record setting amount of novel medical devices in 2020.  In 2020, the FDA’s Center for Devices and Radiological Health gave the... Read More

Supreme Court Allows Government to Enforce Abortion Pill Rule
Supreme Court
Supreme Court Allows Government to Enforce Abortion Pill Rule
2021-01-13 16:39:53
by Dan McCue

WASHINGTON - The U.S. Supreme Court lifted a nationwide injunction Tuesday that had prevented the federal government from enforcing a rule that required women to see a health care professional in person before she'd be given access to a so-called... Read More

2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement
Health
2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement

WASHINGTON (AP) — A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign. The Food and Drug Administration is expected to follow the recommendation for the... Read More

FDA Clears First At-Home, Over-The-Counter COVID-19 Test
Health
FDA Clears First At-Home, Over-The-Counter COVID-19 Test

WASHINGTON — The first COVID-19 test that can be performed entirely from home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription. While availability initially will be limited, the new test and others in... Read More

Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review
Health
Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review

Moderna Inc.’s vaccine is safe and effective for preventing COVID-19, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort. The Food and Drug Administration’s staff said... Read More

FDA Issues Emergency Approval for Pfizer Vaccine, Others Sure to Follow
Health
FDA Issues Emergency Approval for Pfizer Vaccine, Others Sure to Follow
2020-12-11 21:19:29
by Dan McCue

WASHINGTON - Under intense pressure from the White House, the Food and Drug Administration dramatically moved up its timeline, issuing an emergency authorization for Pfizer's COVID-19 vaccine on Friday. The agency had initially planned to finalize its authorization on Saturday,... Read More

FDA Panel Approves Pfizer Vaccine For Nationwide Distribution
Health
FDA Panel Approves Pfizer Vaccine For Nationwide Distribution
2020-12-11 00:13:15
by Tom Ramstack

WASHINGTON -- A federal panel of outside experts on Thursday endorsed a coronavirus vaccine from Pfizer and BioNTech, recommending that the Food and Drug Administration move forward with emergency authorization. President-elect Joe Biden responded with a statement saying, “Today’s approval... Read More

Emergency Approval of Coronavirus Vaccines is Not Guaranteed, FDA Commissioner Says
Health
Emergency Approval of Coronavirus Vaccines is Not Guaranteed, FDA Commissioner Says

WASHINGTON — The Food and Drug Administration will not automatically authorize emergency use of coronavirus vaccines before completing a rigorous independent review, despite heightened expectations that two vaccine candidates will be available to Americans this month, Dr. Stephen Hahn, FDA commissioner, told McClatchy in... Read More

Moderna Seeks Clearance for COVID-19 Vaccine After Strong Test Results
Business
Moderna Seeks Clearance for COVID-19 Vaccine After Strong Test Results

Moderna Inc. requested clearance for its coronavirus vaccine in the U.S. after a new analysis showed the vaccine was highly effective in preventing COVID-19, with no serious safety problems. A Moderna spokesman said in a text message late Monday afternoon that its application for an... Read More

FDA Approves Gilead's Remdesivir as Coronavirus Treatment
Health
FDA Approves Gilead's Remdesivir as Coronavirus Treatment

The U.S. Food and Drug Administration has officially approved remdesivir as a treatment for coronavirus, drug manufacturer Gilead Sciences announced Thursday. The Ebola drug was already being used to treat patients under an emergency-use authorization issued in May, but the latest FDA action makes... Read More

FDA Releases High Coronavirus Vaccine Standards Despite White House Resistance
Health
FDA Releases High Coronavirus Vaccine Standards Despite White House Resistance

WASHINGTON — The Food and Drug Administration issued long-awaited guidance Tuesday on the data it expects from drug companies seeking emergency authorization of COVID-19 vaccines, rejecting White House pressure for lower standards intended to push out vaccines quickly. The 18-page... Read More

Fauci to FDA: ‘I Got Your Back’ on COVID-19 Vaccine Safety Standards
Health
Fauci to FDA: ‘I Got Your Back’ on COVID-19 Vaccine Safety Standards

ATLANTA — The federal government’s top infectious disease official attempted to reassure the public Thursday that he’ll support safety standards set by federal officials for any COVID-19 vaccines and their work won’t be swayed by politics. “If (U.S. Food and... Read More

FDA Blocks Much-Anticipated BioMarin Hemophilia Gene Therapy
Regulation
FDA Blocks Much-Anticipated BioMarin Hemophilia Gene Therapy

FAIRLESS HILLS, PA (AP) — Investors fled drug developer BioMarin in droves on Wednesday, driving shares down by a third after U.S. regulators rejected the company’s potentially game-changing hemophilia A gene therapy over concerns it might not really be a... Read More

FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus
Health
FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus
2020-06-15 19:14:05
by Dan McCue

WASHINGTON - The Food and Drug Administration revoked its emergency authorization of hydroxychloroquine and chloroquine for treating COVID-19 as evidence mounts that the drugs don't work and can cause serious side effects. “We’ve made clear throughout the public health emergency... Read More

FDA Authorizes First At-Home Sample Collection Test for COVID-19
Health
FDA Authorizes First At-Home Sample Collection Test for COVID-19
2020-04-21 20:40:19
by Dan McCue

WASHINGTON - The Food and Drug Administration Tuesday approved the first diagnostic test for the coronavirus that allows people to collect their sample at home -- a development that could greatly expand testing options in states fighting to corral the... Read More

FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus
Courts
FDA Asks Judge to Delay E-Cigarette Deadline, Citing Virus

WASHINGTON — The Food and Drug Administration asked a federal judge to grant a 120-day delay for a deadline for e-cigarette manufacturers to submit applications to keep their products on the market. Citing “the exceptional circumstances presented by the global... Read More

FDA Issues Emergency Approval for Coronavirus Test
In The News
FDA Issues Emergency Approval for Coronavirus Test

The federal government has issued an emergency order allowing its coronavirus test to be used by state health labs nationwide, speeding up efforts to detect and contain new cases of the mysterious new illness. Since the first cases of the... Read More

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