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Category: FDA


FDA, Regulations

United sues FDA to try to block rival’s drug application

February 22, 2024

Via: Pharmaphorum

In an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product. The suit claims that […]


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]


FDA, Regulations

RAPT hit by FDA clinical hold on eczema, asthma drug

February 21, 2024

Via: Pharmaphorum

The stock plunged almost 74% after the announcement of a “serious adverse event” – a case of liver failure – in the trial involving patients with atopic dermatitis, also known as eczema. RAPT said the FDA had “verbally notified” it […]


FDA, Regulations

FDA Expands Use of Asthma Med Xolair to Treat Food Allergies

February 16, 2024

Via: Drugs.com

People threatened by accidental exposure to foods they’re allergic to may have a new weapon of defense: On Friday, the U.S. Food and Drug Administration expanded the use of the asthma drug Xolair to help prevent anaphylactic reactions. Xolair (omalizumab) […]


FDA, Regulations

Ipsen drug approved by FDA for early pancreatic cancer

February 14, 2024

Via: Biopharma Dive

Pancreatic cancer remains one of the most difficult tumors to treat, with few good options after cancerous cells have spread more widely. More than 60,000 people are diagnosed with the adenocarcinoma form each year, according to Ipsen, often after metastases. […]


FDA, Regulations

How Would an FDA Ban on Popular Cold Meds Affect Americans?

February 9, 2024

Via: Drugs.com

America’s most popular cold medications contain a nasal decongestant that doesn’t work, creating a knotty dilemma for regulators, a new study reports. Cold remedies containing phenylephrine remain consumers’ most popular choice, despite decades of concern that the decongestant simply isn’t […]


FDA, Regulations

FDA Warns of Dangerous Counterfeit Eyedrops

February 1, 2024

Via: Drugs.com

Certain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday. The packaging for South Moon, Rebright and FivFivGo eyedrops mirrors the packaging for Bausch & Lomb’s Lumify eyedrops, […]


FDA, Regulations

FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis

January 31, 2024

Via: Biopharm International

Revolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]


FDA, Regulations

FDA Issues Another Warning on Tianeptine Products, Which Can Cause Seizures and Death

January 25, 2024

Via: Drugs.com

Reiterating a warning first issued in November, the U.S. Food and Drug Administration is urging Americans to stay away from supplements containing tianeptine, known on the street as “gas station heroin.” The supplements, sold under the brand name Neptune’s Fix […]


FDA, Regulations

FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk

January 12, 2024

Via: Biopharma Dive

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and […]


FDA, Regulations

FDA to Import Syphilis Drug, Extencilline, From France Amid Shortage

January 11, 2024

Via: Drugs.com

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the […]


FDA, Regulations

5 FDA decisions to watch in the first quarter

January 4, 2024

Via: Biopharma Dive

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]


FDA, Regulations

FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

December 22, 2023

Via: Pharmaphorum

The US approval is the first in the world for Wainua (eplontersen), a once-monthly antisense treatment that can be self-administered by subcutaneous injection. According to AZ and Ionis, it is the only drug for ATTR polyneuropathy that doesn’t need to […]


FDA, Regulations

FDA holds back MSD’s chronic cough drug again

December 21, 2023

Via: Pharmaphorum

The latest complete response letter (CRL) for gefapixant comes even though the drug is already on the market in Europe and Japan under the Lyfnua brand name, and less than two years after the FDA first rejected it in January […]


FDA, Regulations

Cinnamon Tied to Tainted Applesauce Had Lead Levels 2,000 Times Higher Than Proposed Standards, FDA Says

December 19, 2023

Via: Drugs.com

Cinnamon samples gathered at a facility in Ecuador linked to tainted applesauce pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards, according to U.S. Food and Drug Administration inspectors. Tests conducted at […]


FDA, Regulations

FDA says no to Checkpoint’s skin cancer drug cosibelimab

December 19, 2023

Via: Pharmaphorum

Checkpoint Therapeutics’ late entry into the PD-1/PD-L1 inhibitor category, cosibelimab, just got knocked back even further after it was turned down by the FDA as a treatment for skin cancer. A complete response letter (CRL) from the US regulator cites […]


FDA, Regulations

FDA establishes advisory committee for genetic metabolic disease treatments

December 18, 2023

Via: PMLiVE

The Genetic Metabolic Diseases Advisory Committee will advise the FDA on products used for the diagnosis, prevention and treatment of genetic metabolic diseases under the Division of Rare Diseases and Medical Genetics, established in 2020. Genetic metabolic diseases are conditions […]


FDA, Regulations

FDA Asked to Consider Party Drug MDMA as Treatment for PTSD

December 13, 2023

Via: Drugs.com

A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD). When announcing the new drug application (NDA) filing […]


FDA, Regulations

FDA elevates chief scientist Bumpus to the number two role

November 30, 2023

Via: Pharmaphorum

Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf, who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency. “As principal deputy commissioner, […]


FDA, Regulations

FDA approves first therapy for rare type of non-cancerous tumors

November 28, 2023

Via: World Pharma News

The U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype […]