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.

The Maharashtra Food and Drug Administration (FDA) has suspended the operating licenses of a KFC outlet and Baba’s Kitchen in Pune due to identified food safety violations.

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 Food and Drug Administration (FDA) has initiated a crackdown, taking action against 16 establishments, including prominent names like Burger King and Sayaji Hotel.

The Food and Drug Administration (FDA) has suspended the licenses of four Domino's and one Pizza Hut outlet in Mumbai, though the specific reasons were not detailed.

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 Food and Drug Administration (FDA) has ordered the closure of two canteens operating without proper licenses at IIT Bombay, while a third canteen received a notice.

Bombay courts are frequently reversing instant restaurant closure orders issued by the Food and Drug Administration (FDA), indicating a trend of judicial oversight on regulatory actions.

The Food and Drug Administration (FDA) in Maharashtra, India, has issued a directive asking schools to cease the sale of junk food items popular among children.

The Food and Drug Administration (FDA) in Pune, India, has suspended the licenses of 21 food establishments, indicating regulatory action against non-compliant businesses.

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 (FDA) has approved Lipfendra, a novel pill designed to help manage cholesterol levels.

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.

A new rule from the Food and Drug Administration (FDA) is expected to provide advantages for the 'hub-and-spoke' model of drug manufacturing.

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.

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.

The Food and Drug Administration (FDA) has granted permission for Philip Morris International to market its Zyn nicotine pouches with a label indicating they are less harmful than cigarettes. This decision allows for specific health claims on the product.

The Food and Drug Administration (FDA) in Mumbai has suspended six eateries due to severe hygiene violations, including the presence of rats, cockroaches, and rotting or expired food. This crackdown highlights ongoing efforts to ensure food safety standards in the city.

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.

Stem cell technology firm Miracell has achieved a significant milestone by securing clearance from the US Food and Drug Administration (FDA) for its integrated cell-processing system.

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

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 Philippine Food and Drug Administration (FDA) continues to review the application for the new generation anti-dengue vaccine, Qdenga, three years after it was submitted for registration.

Tukaram Mundhe, the new chief of the Food and Drug Administration (FDA), stated that honest businesses have nothing to fear under his leadership.

A report by the Brownstone Institute alleges that the US Food and Drug Administration (FDA) has covered up child deaths linked to Covid vaccines, citing former FDA Commissioner Dr. Marty Makary.

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.

Marty Makary, the head of the Food and Drug Administration (FDA), has resigned from his position under pressure, having faced criticism from both sides of the political aisle.

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

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

A report describes an environment of paranoia, turmoil, and backlash within the Food and Drug Administration (FDA) during the tenure of Marty Makary.

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

A man was apprehended in Cagayan de Oro City, Philippines, for allegedly selling a 'kidney cleanser' food supplement that was not registered with the Food and Drug Administration (FDA).

The Food and Drug Administration (FDA) in Maharashtra has mandated that restaurants must declare the use of analogue paneer and cheese on their menus starting May 1, in an effort to combat 'paneer…

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.

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

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

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

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...

A key US Senator has launched an investigation into the Food and Drug Administration (FDA) regarding its denials of drugs for rare diseases.

A Wall Street Journal opinion piece raises questions about the leadership and decision-making authority within the Food and Drug Administration (FDA).

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 Taiwan Food and Drug Administration (FDA) has stated that recalled US berries, subject to a health alert, were not imported into Taiwan.

Mumbai's civic chief praised the Food and Drug Administration (FDA) drive conducted under Tukaram Mundhe, stating that society sometimes requires such 'shocks'.

Restaurants and government canteens in Mumbai have voluntarily shut down for repairs and deep cleaning as the Food and Drug Administration (FDA) intensifies its crackdown on hygiene standards.

Since taking office three months ago, the Commissioner of the Food and Drug Administration (FDA) in India has reportedly put the state's food and beverage industry on edge, with past actions including raiding a court canteen and razing Dawood's 'palace'.

The US Food and Drug Administration (FDA) is proposing new rules for how food manufacturers notify them of ingredients, closing a loophole but not including a promised definition for 'ultra-processed' foods.

The Maharashtra Food and Drug Administration (FDA) has banned non-dairy paneer, prompting experts to share important information with the public.

The Food and Drug Administration (FDA) in India has revoked the license of the ayurvedic pharmaceutical company Inducare Pharma Pvt Ltd.

The Mumbai Confidential column reports on an internal test conducted by the Food and Drug Administration (FDA). Further details about the nature and outcome of the test were not provided in the snippet.

The Food and Drug Administration (FDA) has stopped business at two canteens within the Bombay High Court premises, with the bar association stating the action was taken 'voluntarily'.

The Food and Drug Administration (FDA) in Maharashtra, India, has issued an order prohibiting the sale of chocolates, chips, and cold drinks in schools.

An advisory panel to the Food and Drug Administration (FDA) has voted in favor of allowing easier access to popular peptide therapies, recommending that specialized pharmacies be permitted to produce them, despite opposing recommendations from agency scientists.

The Food and Drug Administration (FDA) has identified a source for a recent outbreak of a diarrhea-causing parasite, though the full scope of the saga is not yet over. The investigation continues into the incident.

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.

HLB's liver cancer treatment has encountered another obstacle in its bid to enter the US market, as the US Food and Drug Administration (FDA) issued a Complete Response Letter. The delay is attributed to manufacturing compliance issues rather than concerns about the drug's efficacy.

In an exclusive interview, Maharashtra Food and Drug Administration (FDA) chief Tukaram Munde emphasized the critical need to strengthen the agency's manpower to ensure citizens receive safe food and medicines.

Experts are raising concerns that a series of recent baby formula recalls due to bacterial contamination may be linked to staff reductions at the Food and Drug Administration (FDA) during the Trump administration, suggesting the agency is ill-prepared for such health threats.

The US Food and Drug Administration (FDA) claims that Irish pharmaceutical company Genzyme produced 'adulterated products' after inspecting its facility near Waterford city and finding significant violations.

A Food and Drug Administration (FDA) panel discussing peptides will reportedly include experts who advocate for unproven chemicals, a topic favored by figures like RFK Jr.

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 Food and Drug Administration (FDA) has withdrawn its complaint against Whoop regarding its blood pressure tracking tool. This decision clears the path for the health technology company.

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.

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 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 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.

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.

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.

Kyle Diamantas, a former lawyer and deputy commissioner for food, has been appointed as the new acting commissioner of the US Food and Drug Administration (FDA).

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

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 (FDA) is reportedly conducting an unannounced inspection at the facilities of pharmaceutical company Alvotech in Iceland.

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 as a Modified Risk Tobacco Product (MRTPA).

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.

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.

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

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

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).

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 Philippine Food and Drug Administration (FDA) has placed major retail chains Landers Superstore and S&R Membership Shopping under scrutiny after inspections revealed unregistered and improperly labeled products.

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).

India's Food and Drug Administration (FDA) has requested explanations from actors Shah Rukh Khan, Ajay Devgn, and Tiger Shroff regarding their involvement in a Vimal Elaichi advertisement.

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.

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.

India's Food and Drug Administration (FDA) has seized sub-standard edible oil worth Rs 1.94 crore in Beed and subsequently suspended the licenses of five establishments involved.

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.

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.

Hotel associations in Maharashtra are urging Prime Minister Modi and Deputy Chief Minister Fadnavis to intervene following a crackdown by the state's Food and Drug Administration (FDA).

The head of Maharashtra's Food and Drug Administration (FDA), Tukaram Mundhe, is facing a complaint regarding staff shortages, at a time when the FDA is conducting a major crackdown on food joint operators violating safety standards.

President Ferdinand Marcos Jr. has appointed Atty. Paolo Teston, former director general of the Food and Drug Administration (FDA), as a new associate justice of the Court of Tax Appeals.

Toni Daa Dhaba and eleven other establishments are facing action from the Food and Drug Administration (FDA) due to identified hygiene lapses.

The Food and Drug Administration (FDA) has suspended the license of Mumbai's iconic 110-year-old Parsi Dairy Farm due to hygiene and safety lapses in its production area. This action follows an inspection that revealed significant issues.

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 United States Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj), a first-in-class treatment developed by Vera Therapeutics, aimed at reducing proteinuria in adults with primary immunoglobulin A nephropathy.

The Maharashtra Food and Drug Administration (FDA) has intensified its efforts against milk adulteration, implementing stricter regulations for the supply chain to ensure quality and safety.

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.

The US Food and Drug Administration (FDA) has upgraded a recall for an estimated 650,000 bags of popular potato chip brands to its most serious level due to a potential salmonella risk.

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 Food and Drug Administration (FDA) will hold a committee meeting in July to discuss potentially easing restrictions on peptides, which are currently sold in a gray market despite limited evidence of safety and efficacy.

The Food and Drug Administration (FDA) has renewed its efforts to crack down on companies compounding GLP-1 drugs.

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

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.

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.

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.

An opinion article discusses the potential for new leaders at the Food and Drug Administration (FDA) to foster innovation. It likely examines how new policies or approaches could impact the industry.

The US Senate has cleared the path for lawyer and financial expert Kevin Warsh to succeed Jerome Powell as the next head of the Federal Reserve. Separately, the head of the US Food and Drug Administration (FDA) has announced his resignation.

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.

The head of the Food and Drug Administration (FDA), Dr. Makary, has defended the agency's decisions to reject certain drug applications, following recent criticism.

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 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.

A quiet battle has been unfolding inside the US Food and Drug Administration (FDA) for months, reportedly beginning with an analysis of child deaths.

Arbutus Biopharma announced that its lead drug candidate has received Fast Track designation from 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.

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

MANILA, Philippines—The Food and Drug Administration (FDA) on Wednesday said the controlled destruction of infant formula products, earlier recalled by Nestlé Philippines, began this week, marking…

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.

FDA Dropping Requirement For 2 Studies For New Drug Approvals Authored by Zachary Stieber via The Epoch Times (emphasis ours), The Food and Drug Administration (FDA) will approve many new drugs based on one trial moving forward, agency leaders have said. FDA Commissioner Dr. Marty Makary in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images The FDA has typically required two studies from companies seeking approval for most new drugs, although in recent years it has ap...