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Category: FDA


FDA, Regulations

Bristol Myers Squibb’s Breyanzi granted FDA accelerated approval for non-Hodgkin lymphomas

March 18, 2024

Via: PMLiVE

The regulator’s decision specifically applies to adult patients with relapsed or refractory disease who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. CLL is one of the […]


FDA, Regulations

BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

March 18, 2024

Via: PMLiVE

The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost […]


FDA, Regulations

FDA Approves First Drug for Common, Serious Liver Disease

March 15, 2024

Via: Drugs.com

Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is called non-cirrhotic non-alcoholic steatohepatitis (NASH). […]


FDA, Regulations

FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma

March 13, 2024

Via: Biopharma Dive

Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions about whether they should be earlier in a patient’s disease, Food and Drug Administration scientists wrote in a briefing document […]


FDA, Regulations

FDA Delays Decision on New Alzheimer’s Drug

March 8, 2024

Via: Drugs.com

Instead of approving the new Alzheimer’s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the drug’s maker said Friday. “The FDA […]


FDA, Industry, Regulations, Vaccines

Vaccines Protect You & Your Kids From Measles: FDA

March 4, 2024

Via: Drugs.com

As new outbreaks of measles — a once nearly eliminated illness in the United States — continue to emerge, experts remind Americans that there’s an easy way to stop infection: Get vaccinated. “Measles spreads so easily that if one person […]


FDA, Regulations

Say Goodbye to PFAS Chemicals in Food Packaging: FDA

February 28, 2024

Via: Drugs.com

PFAS “forever” chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. Food and Drug Administration announced Wednesday. “Grease-proofing materials containing per- and polyfluoroalkyl substances [PFAS] are no longer being […]


FDA, Regulations

Minerva schizophrenia drug rejected by FDA

February 27, 2024

Via: Biopharma Dive

The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]


FDA, Regulations

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024

Via: PMLiVE

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]


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 […]