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Category: FDA


Cell and Gene Therapy, FDA, Industry, Regulations

uniQure, CSL claim first okay for haemophilia B gene therapy

November 23, 2022

Via: Pharmaphorum

The adeno-associated virus (AAV) vector-based therapy is given as a one-shot intravenous infusion, delivering a gene for Factor IX, a clotting factor that is deficient in haemophilia B. In trials, it cut the annualised bleed rate for patients, as well […]


FDA, Regulations

FDA Approves First Drug to Delay Onset of Type 1 Diabetes

November 18, 2022

Via: Drugs.com

The U.S. Food and Drug Administration on Thursday approved the first drug that could delay the development of type 1 diabetes (T1D). Teplizumab (Tzield) targets the autoimmune issues that drive the disease, rather than its symptoms, making the medication a […]


FDA, Regulations

Using an Online Pharmacy to Buy Meds? It’s Buyer Beware, FDA Says

November 18, 2022

Via: Drugs.com

It might be tempting to buy prescription medication online, but buyers should beware, the U.S. Food and Drug Administration warns. While some pharmacy websites operate legally and can offer convenience, privacy and lower costs, others may be selling unapproved, counterfeit […]


FDA, Regulations

FDA Approves First Lab-Grown Meat Product

November 17, 2022

Via: Drugs.com

Americans could soon be eating chicken that’s grown in a lab from cultured animal cells, rather than raised at a farm or facility. The U.S. Food & Drug Administration announced Wednesday that the environment-friendly chicken made by California-based Upside Foods […]


FDA, Regulations

FDA panel backs Ardelyx CKD drug, despite agency concerns

November 17, 2022

Via: Pharmaphorum

The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted yesterday by nine to four that the benefits of Xphozah (tenapanor) outweigh its risks when given as a monotherapy to treat high phosphate levels in the blood in adults with CDK […]


FDA, Regulations

FDA advisory committee recommends Ardelyx’s Xphozah for chronic kidney disease

November 17, 2022

Via: PMLiVE

The committee voted nine to four in favour of Xphozah – a phosphate absorption inhibitor – to be administered as a monotherapy for treating this patient population, and voted ten to two, with one abstention, for the drug’s use alongside […]


FDA, Regulations

FDA Approves Drug Combo for Metastatic Non-Small Cell Lung Cancer

November 16, 2022

Via: Drugs.com

The U.S. Food and Drug Administration approved the combination of tremelimumab (Imjudo) plus durvalumab (Imfinzi) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic […]


FDA, Regulations

FDA Moves Toward Making Overdose Antidote an Over-the-Counter Drug

November 16, 2022

Via: Drugs.com

The U.S. Food and Drug Administration appears poised to approve certain naloxone products for over-the-counter use, a move that would help fight the nation’s opioid epidemic. Naloxone (Narcan, Evzio) can save lives when administered soon after the first signs of […]


FDA, Regulations

FDA declines to review Brainstorm’s ALS therapy

November 11, 2022

Via: Biopharma Dive

The FDA’s choice marks the latest setback for the NurOwn program. When that key, late-stage clinical trial failed in late 2020, Brainstorm’s CEO Chaim Lebovits said the company was confident there would be a path forward for its medicine. Brainstorm […]


FDA, Regulations

Sobi’s Kineret granted FDA Emergency Use Authorisation for COVID-19 related pneumonia

November 11, 2022

Via: PMLiVE

Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1α and β, which play a role in COVID19-induced hyperinflammation. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on […]


Clinical Trials, FDA, Regulations, Research and Development

FDA approves Seagen’s Adcetris combination for paediatric patients with Hodgkin lymphoma

November 11, 2022

Via: PMLiVE

The FDA’s decision was based on positive results from the phase 3 AHOD1331 study in which patients receiving the combination treatment achieved superior event-free survival compared to patients who received standard of care chemotherapy alone. AHOD1331 is, as the company […]


Clinical Trials, FDA, Regulations, Research and Development

FDA panel backs AZ’s PT027 asthma rescue drug, but in adults only

November 9, 2022

Via: Pharmaphorum

PT027 is based on beta agonist albuterol and corticosteroid budesonide – two well-established therapies – combined into a fixed-dose inhaler that can be used as rescue medication when a patient with asthma is in the throes of an attack. The […]


Clinical Trials, FDA, Regulations, Research and Development

FDA blocks early filing for ADC drug, signalling tougher stance

November 9, 2022

Via: Pharmaphorum

The Swiss biotech said that enrolling such a study would take up to two years, and its plan to file for approval of the drug next year is on hold while it is in dialogue with the FDA about a […]


Clinical Trials, FDA, Regulations, Research and Development

Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

November 9, 2022

Via: PMLiVE

Specifically, the treatment is indicated for patients with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS1 aberrations, and those eligible for treatment must either have metastatic or locally advanced tumours that are not candidates for surgical […]


FDA, Industry, Regulations, Vaccines

GSK’s respiratory syncytial virus older adult vaccine given Priority Review by FDA

November 2, 2022

Via: PMLiVE

Priority Reviews are granted by the FDA in response to applications for vaccines that, if approved, have the potential to offer significant improvements in the safety or effectiveness of the treatment or prevention of critical conditions when compared to standard […]


FDA, Manufacturing, Regulations, Research and Development

Lannett Expands Liquid Drug Manufacturing Capabilities

October 31, 2022

Via: Contract Pharma

Lannett Company, Inc. has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino, the company’s branded topical anesthetic product, at its main plant in Seymour, IN. The company previously manufactured Numbrino and other liquid drug products […]


Clinical Trials, FDA, Regulations, Research and Development

What the FDA’s guidance on diversity means for rare disease sponsors

October 31, 2022

Via: Biopharma Dive

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. This plan, designed to help make clinical trial enrollment more representative, stands to support diversity, equity and […]


FDA, Regulations

FDA Warns of Amoxicillin Shortage

October 31, 2022

Via: Drugs.com

It could be harder to fill a prescription for the widely used antibiotic amoxicillin because of a shortage that appears to be linked to an ongoing surge in RSV infections across the United States. Supplies of amoxicillin oral solution, which […]


FDA, Regulations

GSK’s anaemia drug gets FDA advisory committee support for patients on dialysis

October 28, 2022

Via: PMLiVE

The advisory committee experts, however, voted 11 to five against the use of daprodustat in non-dialysis patients with anaemia of CKD, citing increased safety risks such as heart failure and bleeding gastric erosions. The FDA will consider the vote, feedback […]


FDA, Regulations

Santhera seeks speedy FDA review of Duchenne drug vamorolone

October 28, 2022

Via: Pharmaphorum

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. Santhera should hear from the FDA […]