The U.S. Food and Drug Administration has officially accepted Kowa Pharmaceuticals' new drug application for a novel ophthalmic solution aimed at treating glaucoma.

The U.S. Food and Drug Administration has issued a nationwide recall of certain thyroid medications after testing revealed potential superpotency that could pose serious health risks to patients.

The U.S. Food and Drug Administration (FDA) has extended the PDUFA target action date for Capricor Therapeutics' Biologics License Application (BLA) for deramiocel to November 22. This extension allows the FDA more time to complete its review of the drug.

The U.S. Food and Drug Administration (FDA) has accepted United Therapeutics' application for ralinepag, a drug intended for the treatment of Pulmonary Arterial Hypertension (PAH).

The U.S. Food and Drug Administration has issued a recall for 19 million eggs, including 1.6 million dozen, due to potential Salmonella contamination. This recall has been classified under the FDA's highest risk level.

The U.S. Food and Drug Administration (FDA) has proposed new regulations that would require food manufacturers to notify the agency before introducing new ingredients and additives into their products.

The U.S. Food and Drug Administration has given its approval for Moderna's mRNA-based influenza vaccine, marking a significant development in flu prevention.

Biopharmaceutical company Oculis has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its plans to develop Privosegtor, a drug substance intended for the treatment of acute multiple sclerosis exacerbations.

The U.S. Food and Drug Administration has given its approval to Freenome's new blood test, designed for the screening of colorectal cancer.

The U.S. Food and Drug Administration's key drugs advisory committee, recently reconstituted, is now reviewing seven popular peptides touted for weight loss, healing, and longevity, addressing their use for conditions like obesity and insulin resistance.

The U.S. Food and Drug Administration has approved a new once-daily medication designed to reduce bad cholesterol levels. The article explains how the pill works and identifies potential beneficiaries of this new treatment.

The U.S. Food and Drug Administration (FDA) has granted priority review for the label expansion of a kidney drug developed by Roche and Biogen.

Philip Morris International has announced that the U.S. Food and Drug Administration (FDA) has approved a modified risk claim for 20 of its ZYN products. This approval signifies a significant regulatory milestone for the company.

Hybio Pharmaceuticals' generic version of a weight-loss drug is reportedly slated for review by the U.S. Food and Drug Administration.

Tobacco stocks saw an uptick after the U.S. Food and Drug Administration (FDA) proposed a new rule concerning foreign manufacturers, signaling potential changes in the regulatory landscape for the industry.

The U.S. Food and Drug Administration has sent 25 letters to telehealth companies, cautioning them about claims made regarding compounded weight-loss drugs.

The U.S. Food and Drug Administration (FDA) has approved a new chemical compound for use in sunscreens, which will soon allow people to enjoy sunbathing more frequently with enhanced protection.

The U.S. Food and Drug Administration has approved a new sunscreen ingredient, marking the first such approval in two decades. The ingredient has been in use for many years in Europe and Asia.

The U.S. Food and Drug Administration (FDA) has issued an urgent recall for a popular sexual enhancement chocolate product, 'Boner chocolate,' after laboratory analyses revealed it secretly contained the active ingredient of Viagra, posing a dangerous health risk to consumers.

Advisers to the U.S. Food and Drug Administration (FDA) have backed the XFG strain for the 2026-2027 COVID-19 vaccine update. This decision follows a routine review of vaccine composition to combat evolving variants.

Staff at the U.S. Food and Drug Administration were reportedly caught off guard by a move that permits additional e-cigarettes and nicotine pouches to enter the American market.

AstraZeneca has announced that its hypertension drug, Baxfendy, has received approval from the U.S. Food and Drug Administration (FDA). This approval marks a significant step for the treatment of hypertension.

Alvotech's shares increased following the completion of the U.S. Food and Drug Administration's inspection of its manufacturing facility located in Reykjavik, Iceland.

The U.S. Food and Drug Administration (FDA) has announced a significant policy change by authorizing the sale of fruit-flavored e-cigarettes. This decision represents a major shift in the agency's approach to vaping products.

The U.S. Food and Drug Administration has proposed removing certain weight-loss drugs from the list of medications that can be compounded, potentially impacting their availability.

Pharmaceutical giant AbbVie has received a rejection from the U.S. Food and Drug Administration (FDA) regarding its new wrinkle drug, citing unresolved manufacturing issues.

The U.S. Food and Drug Administration (FDA) has renewed the authorization for Philip Morris International's IQOS heated tobacco products as modified risk tobacco products.

The U.S. Food and Drug Administration has accepted Roche's application for its drug Gazyva/Gazyvaro, intended for the treatment of common lupus.

The U.S. Food and Drug Administration is moving forward with plans to reassess restrictions on certain popular peptides, including scheduling an Advisory Committee meeting to decide on potentially lifting them. This development has led to a jump in Hims & Hers stock.

The U.S. Food and Drug Administration has mandated that pharmaceutical company Lilly perform post-marketing studies for its obesity medication.

Biopharmaceutical company Replimune plans layoffs after the U.S. Food and Drug Administration rejected its cancer drug, impacting the company's workforce and future plans.

MacroGenics announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on its lead development program.

The U.S. Food and Drug Administration has granted market approval to Eli Lilly for its new weight-loss pill, making it available soon.

Biogen has received approval from the U.S. Food and Drug Administration for its high-dose Spinraza regimen, a treatment for spinal muscular atrophy.

Sanofi has announced that its drug Venglustat has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).

Johnson & Johnson said the U.S. Food and Drug Administration approved its once-daily psoriasis pill, the first oral option to rival best-selling shots.

The U.S. Food and Drug Administration (FDA) is reportedly planning to ease testing requirements for biosimilar drugs, a move aimed at making it easier and faster to bring these less expensive alternatives to market.

The U.S. Food and Drug Administration has issued four observations to a formulation unit belonging to a subsidiary of Aurobindo Pharma.

The U.S. Food and Drug Administration has granted approval to Lisraya, developed by Priovant, marking a new therapeutic option for patients suffering from dermatomyositis.

The U.S. Food and Drug Administration (FDA) has granted approval to Johnson & Johnson's drug Imaavy. This new treatment is approved for warm autoimmune hemolytic anemia, a rare blood disorder.

Humacyte, a biotechnology company, is preparing to submit a filing to the U.S. Food and Drug Administration (FDA) in November for its dialysis access product.

Regeneron has secured approval from the U.S. Food and Drug Administration (FDA) for its new therapy designed to treat a rare bone disorder.

The U.S. Food and Drug Administration (FDA) has approved an mRNA flu vaccine, a development considered a major breakthrough in vaccine technology and public health. The new jab is expected to offer improved protection against influenza.

Tanning influencers are actively promoting Melanotan II, dubbed the 'Barbie peptide', despite it not being approved by the U.S. Food and Drug Administration and carrying significant health risks.

The U.S. Food and Drug Administration has approved Moderna's flu vaccine, leading to a significant increase in the company's stock value.

The U.S. Food and Drug Administration is expected to decide whether to approve the first mRNA flu vaccine, a development that could mark a significant advancement in vaccine technology.

The U.S. Food and Drug Administration is evaluating Moderna's mRNA-based flu vaccine, which could be the first of its kind on the market, a decision expected to impact the biotech industry.

The U.S. Food and Drug Administration has given its approval for the first pill designed to replace injectable treatments for managing high cholesterol levels.

The U.S. Food and Drug Administration has announced it is investigating a separate cyclospora outbreak, distinct from previous incidents.

The U.S. Food and Drug Administration (FDA) has approved Lipfendra, a novel pill designed to help manage cholesterol levels.

The U.S. Food and Drug Administration (FDA) has accepted BioMarin's supplemental New Drug Application (sNDA) seeking full approval for its drug Voxzogo.

The U.S. Food and Drug Administration (FDA) has decided that 20 variants of ZYN nicotine pouches can be categorized as modified risk nicotine products, making ZYN the first of its kind to receive such approval.

NeuroPace, Inc. announced that its ECoG Assistant™ has received approval from the U.S. Food and Drug Administration (FDA). This approval marks a significant milestone for the company and its product in the medical device market.

The U.S. Food and Drug Administration has approved the world's first mRNA-based flu vaccine, intended for people 50 and older. This approval marks a significant step in illness prevention, as trials showed the vaccine to be more effective than standard flu shots.

The U.S. Food and Drug Administration (FDA) has accepted Gilead's supplemental New Drug Application (sNDA) for its weekly Yeztugo HIV pill.

The U.S. Food and Drug Administration (FDA) has accepted Inhibrx's Biologics License Application (BLA) for ozekibart.

Alvotech shares jumped after the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for a biosimilar to Entyvio for review. This development marks a significant step for Alvotech in bringing its biosimilar to market.

The U.S. Food and Drug Administration (FDA) has granted priority review status to Roche's breast cancer drug, giredestrant. This designation accelerates the review process for drugs that could offer significant improvements over existing treatments.

Advisers to the U.S. Food and Drug Administration (FDA) have recommended that COVID-19 vaccines be updated to specifically target the currently dominant variant of the virus.

Moderna's experimental flu shot is scheduled to face a review by the U.S. Food and Drug Administration's (FDA) advisory committee. This review is a crucial step in the approval process for the vaccine.

The U.S. Food and Drug Administration (FDA) is requesting public feedback on the process of repurposing existing drugs for new medical indications.

The U.S. Food and Drug Administration (FDA) has extended its review period for Biogen's Alzheimer's injection, Leqembi, delaying a decision on its approval.

U.S. Food and Drug Administration Commissioner Marty Makary has defended the agency's drug approval decisions in an interview, following a wave of backlash.

The U.S. Food and Drug Administration (FDA) has announced that its largest ever probe into baby formula found the U.S. supplies to be safe. This reassures consumers about the quality of domestic infant formula.

The U.S. Food and Drug Administration (FDA) has taken steps to fast-track the review process for three different psychedelic drugs. This move could potentially accelerate their approval for medical use.

The stock price of Hims & Hers Health, Inc. reacted strongly following a crucial review by the U.S. Food and Drug Administration. The market's response indicates the significance of the FDA's findings for the company's future.

The U.S. Food and Drug Administration (FDA) has reauthorized the marketing of IQOS as a modified risk tobacco product, making Philip Morris International the sole company with such authorizations for heated tobacco products.

Eli Lilly has announced that the U.S. Food and Drug Administration (FDA) has requested additional clinical data regarding its experimental obesity pill, potentially delaying its approval.

Arbutus Biopharma announced that its lead drug candidate has received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Praxis Precision Medicine's stock saw gains after its lead asset was accepted for review by the U.S. Food and Drug Administration.

Telix Pharmaceuticals saw its stock increase after its imaging agent for brain cancer received a review designation from the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration has declined to issue specific guidance regarding the import of prescription drugs from overseas by health programs. This decision follows a CNBC investigation that highlighted the proliferation of such programs, which regulators consider a violation of import laws.

The U.S. Food and Drug Administration (FDA) has confirmed that Amgen's drug Tavneos is linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

The U.S. Food and Drug Administration has approved Novo Nordisk's insulin injection for the treatment of type 2 diabetes. This approval marks a new development in diabetes management.

The U.S. Food and Drug Administration (FDA) has granted approval for Denali Therapeutics' new therapy designed to treat a genetic disorder in children.

FDA Unveils New Platform For Tracking Side Effects Authored by Zachary Stieber via The Epoch Times (emphasis ours), The Food and Drug Administration on March 11 made public a new, consolidated platform for tracking side effects experienced by people following receipt of vaccines and drugs. The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times Officials are folding a number of existing platforms into the Adverse Event M...

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) plans to offer bonus payments to its staffers who successfully complete speedy drug reviews, aiming to accelerate the approval process for new medications.

The U.S. Food and Drug Administration has accepted an investigational new drug application for a Phase 2 Alzheimer’s cognition trial while also approving a novel narcolepsy therapy that targets the underlying disease mechanism. These regulatory moves mark significant progress in developing targeted neurological treatments.

Spruce Biosciences has successfully concluded its pre-Biologics License Application (BLA) meetings with the U.S. Food and Drug Administration (FDA) for its MPS IIIB therapy.

The U.S. Food and Drug Administration has approved an autoinjector version of LEROCHOL® (lerodalcibep-liga) along with an updated indication for the drug.

The U.S. Food and Drug Administration (FDA) has proposed changes to regulations that would require food manufacturers to notify the agency before introducing new ingredients or additives.

The U.S. Food and Drug Administration (FDA) has granted approval for Replimune's melanoma drug, marking a successful outcome after the company's third attempt to secure approval.

The U.S. Food and Drug Administration has given its approval for the first-ever mRNA-based influenza vaccine.

The U.S. Food and Drug Administration is nearing a decision on whether to approve the first flu vaccine utilizing mRNA technology, similar to that used in COVID-19 vaccines. The development comes amidst ongoing public discourse, including skepticism from figures like Robert F. Kennedy Jr. regarding mRNA vaccines.

The U.S. Food and Drug Administration (FDA) has issued a nationwide recall for the thyroid medication levothyroxine.

The U.S. Food and Drug Administration is evaluating whether compounding pharmacies should be permitted to produce certain peptides, including BPC-157 and TB-500, which were previously banned.

The U.S. Food and Drug Administration has issued an apology to Taylor Farms for erroneously claiming that the company's supplier was linked to lettuce contaminated with the diarrhea-causing parasite cyclospora.

Merck's new cholesterol pill has received approval from the U.S. Food and Drug Administration (FDA). This powerful new medication is expected to offer a significant treatment option for patients.

Agios Pharmaceuticals experienced a significant surge in its stock value, attributed to a development related to the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) has listed a recall for Insulet's Omnipod insulin management system as a Class I recall, indicating the most serious type of recall.

Lantheus Holdings, Inc. has announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application for LNTH-2501.

The U.S. Food and Drug Administration has granted approval to GSK and Spero for the first-ever oral carbapenem antibiotic, intended for the treatment of complicated urinary tract infections.

The U.S. Food and Drug Administration has issued a warning to Happiest Baby, the maker of the $1,700 Snoo Smart Sleeper baby bassinets, though the specific reason for the warning is not detailed in the headline.

The U.S. Food and Drug Administration has approved a new sunscreen, marking the first such approval in over 20 years. The new chemical is reported to offer improved efficacy and a better feel.

Icelandic pharmaceutical company Alvotech has applied to the U.S. Food and Drug Administration (FDA) for market authorization for its drug AVT16, as announced in a stock exchange filing today.

The U.S. Food and Drug Administration (FDA) has put forward a proposal to accelerate the development of gene therapies by leveraging existing scientific knowledge. This initiative aims to streamline the process for bringing new gene therapies to patients.

An advisory committee to the U.S. Food and Drug Administration (FDA) is set to evaluate an updated COVID-19 vaccine specifically designed to target the XFG subvariant.

Pharmaceutical company Bayer announced that its drug Sevabertinib has been granted Priority Review status by the U.S. Food and Drug Administration (FDA), as reported by TradingView.

Zai Lab announced that its cancer drug, zocilurtatug pelitecan, has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).

Nuvation's application to expand the label for its drug Ibtrozi is currently undergoing review by the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration (FDA) is reportedly conducting an unannounced inspection at the facilities of pharmaceutical company Alvotech in Iceland.

The U.S. Food and Drug Administration (FDA) has announced that testing confirms the safety of the domestic infant formula supply.

The U.S. Food and Drug Administration has granted Fast Track designation to Kymera Therapeutics, Inc.'s KT-621 for the treatment of eosinophilic asthma. This designation aims to expedite the development and review of drugs for serious conditions.

The U.S. Food and Drug Administration (FDA) has renewed the authorization for Philip Morris International's IQOS as a Modified Risk Tobacco Product (MRTPA).

The U.S. Food and Drug Administration has broadened the use of Sanofi's drug Tzield, allowing it to be administered to children as young as one year old to delay the onset of type 1 diabetes.

Savara Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its lead drug candidate, potentially delaying its approval decision.

Replimune Group Inc. saw its stock price fall by 64% after the U.S. Food and Drug Administration rejected its application for a new drug.

An article discusses the need for global health governance to reduce its reliance on the U.S. Food and Drug Administration (FDA).

Boston Scientific has announced that its Asurys Fluid Management System has received clearance from the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration (FDA) has stated that Amgen's drug Tavneos has been linked to cases of liver injuries and deaths, as reported by the Wall Street Journal.

Dianthus's stock rose after the U.S. Food and Drug Administration (FDA) agreed to proposed changes for the company's lead program.

A unit of Aurobindo Pharma's arm in Rajasthan, India, has been classified as 'Official Action Indicated' (OAI) by the U.S. Food and Drug Administration.

Inovio Pharmaceuticals Inc. (NASDAQ: INO) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational DNA medicine INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP).

Novo Nordisk's shares see a boost after the U.S. Food and Drug Administration issues warning letters to telehealth companies for making false claims.

The U.S. Food and Drug Administration plans to provide bonuses to its staff as an incentive to accelerate the review process for new drugs.