FDA Clears Path For Abortion Pills At Pharmacies
FDA Clears Path For Abortion Pills At Pharmacies Laurel Duggan on January 3, 2023 The Food and Drug Administration (FDA) will allow pharmacies to dispense the abortion-inducing drug mifepristone, the agency announced…
U.S. FDA advisers recommend inclusion of Omicron component for COVID boosters
(Reuters) – Advisers to the U.S Food and Drug Administration on Tuesday overwhelmingly recommended the inclusion of an Omicron component for COVID-19 booster vaccines in the fall. The panel of advisers voted…
Former CEO of Drug Manufacturing Company Pleads Guilty to Conspiring to Defraud the FDA and Distributing Adulterated Drugs
Miami, Florida – Raidel Figueroa, the former CEO and co-owner of Pharmatech, LLC, a drug and dietary supplement manufacturer that operated in Broward County, Florida, pled guilty to conspiring to defraud the…
U.S. FDA advisers back Moderna COVID-19 vaccine for small children
(Reuters) – U.S. Food and Drug Administration advisers on Wednesday recommended the authorization of Moderna Inc’s COVID-19 vaccine for children aged 6 months through 5 years, an important step toward immunizing millions…
Pfizer COVID vaccines safe and effective for small children, FDA staff say
(Reuters) – U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years. The FDA reviewers…
FDA requires disclosure of suicide risk for anti-baldness drug
By Dan Levine (Reuters) – U.S. health regulators rejected a request to remove popular anti-baldness pill Propecia and its generic versions from the market, but for the first time required patient notification…
Novavax shares jump as FDA panel backs COVID vaccine
(Reuters) – Shares of Novavax Inc surged nearly 20% on Wednesday after advisers to the Food and Drug Administration overwhelmingly backed the use of its COVID-19 vaccine, bringing the shot a step…
FDA withdraws approval for TG Therapeutics cancer treatment
(Reuters) -The U.S. Food and Drug Administration said on Wednesday it has withdrawn its approval for TG Therapeutics Inc’s lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients…
FDA presses pause on trial for OTC version of anti-impotence drug Cialis
By Tassilo Hummel and Natalie Grover PARIS/LONDON -The U.S. health regulator has put on hold a trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment,…
Biden has confidence in the FDA and its commissioner, White House says
WASHINGTON – U.S. President Joe Biden has confidence in the U.S. Food and Drug Administration (FDA) and its commissioner Robert Califf, White House press secretary Karine Jean-Pierre said on Thursday, when asked…
Reckitt working with FDA on expediting baby formula imports from Mexico
By Richa Naidu LONDON – Enfamil maker Reckitt Benckiser said on Wednesday that it is working “extremely closely” with the U.S. Food & Drug Administration (FDA) on ways to increase baby formula…
U.S. FDA sets June meeting dates for Moderna, Pfizer small children COVID-19 vaccines
WASHINGTON -The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc’s emergency authorization request for its COVID-19 vaccine for children aged 6 months to…
FDA To Relax Baby Formula Import Rules Amid Shortage
FDA To Relax Baby Formula Import Rules Amid Shortage Laurel Duggan on May 17, 2022 The Food and Drug Administration (FDA) is relaxing import rules for baby formula amid a national shortage…
Joe Biden’s FDA Commissioner Says There is No Baby Formula Shortage
President Joe Biden’s FDA Commissioner Robert Califf claimed there is no baby formula shortage, just a “distribution problem,” during a segment on CNN’s “New Day” with Brianna Keilar and John Berman. Califf…
FDA Finds No Evidence of Bacteria at Shuttered Baby Formula Facility that Sparked Crisis
STURGIS, MI – The FDA has allowed the Abbott company’s Sturgis baby formula manufacturing plant to reopen after shutting down the plant for three months sparking a nationwide baby formula shortage and…
FDA declines to authorize common antidepressant as COVID treatment
By Leroy Leo and Michael Erman (Reuters) – The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown…
Imported infant formula could help lift U.S. supply in weeks -FDA chief
WASHINGTON – The Food and Drug Administration will outline a plan next week to streamline imports of infant formula, the agency’s chief said on Friday, adding that the action along with others…
U.S. FDA commissioner to testify about infant formula before House panel next week
(Reuters) – U.S. Food and Drug Administration Commissioner Robert Califf is set to testify before the House Appropriations Committee on May 19 his agency’s resposne to an infant formula shortage in the…
U.S. FDA moves forward with proposal to ban menthol cigarettes
(Reuters) – The U.S. Food and Drug Administration on Thursday issued a long-awaited proposal to ban menthol cigarettes and flavored cigars, in a major victory for anti-smoking advocates but one that could…
Pfizer to start U.S. trial of gene therapy as FDA lifts hold
(Reuters) – Pfizer Inc said on Thursday it would open the first U.S. trial sites for its experimental gene therapy for a muscle-wasting disorder, after the Food and Drug Administration lifted its…
FDA warns websites illegally selling ADHD drug Adderall
(Reuters) – The U.S. Food and drug Administration and the U.S. Drug Enforcement Administration have jointly issued warning letters to two websites for illegally selling Adderall, a treatment for attention deficit hyperactivity…
PEREGRINE VENTURES REALIZES USD 500 MILLION EXIT FROM CARTIHEAL FOLLOWING FDA APPROVAL OF IMPLANT FOR TREATMENT OF CARTILAGE AND OSTEOCHONDRAL DEFECTS USA – English USA – English
“Upon first hearing of CartiHeal’s groundbreaking technology, we knew of the company’s immense potential. In fact, we were CartiHeal’s first investors,” said Peregrine’s Co-founder and Managing General Partner, Boaz Lifschitz. “Over USD…
Former CEO of Drug Manufacturing Company Charged with Conspiring to Defraud the FDA and Distributing Adulterated Drugs
Miami, Florida – Raidel Figueroa, the former CEO and co-owner of Pharmatech, LLC, a drug and dietary supplement manufacturer that operated in Broward County, Florida, has made his initial appearance in Fort…
FDA Roundup: April 1, 2022
SILVER SPRING, Md., April 1, 2022 — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices:…
FDA approves CartiHeal’s Implant for the Treatment of Cartilage and Osteochondral Defects
KFAR SABA, Israel, March 30, 2022 — CartiHeal Ltd, developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today announced that the U.S. Food and Drug…
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma
Each year, approximately 8,000 individuals in the U.S. are diagnosed with CCA,1 a rare cancer of the bile ducts of the liver, and approximately 0.3-6 people per 100,000 individuals live with CCA…
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