Tag: FDA

September 20, 2023

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA […]

September 18, 2023

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have […]

September 18, 2023

On Sept. 15, 2023, FDA announced the publication of a draft guidance to assist sponsors of biosimilars and interchangeable biosimilars develop draft labeling. The labeling recommendations are only for prescribing information, “except for certain recommendations in section V, FDA-Approved Patient […]

September 18, 2023

Millions of eligible people in England can now book their vaccine via the NHS website, the NHS app, or by calling 119 for free if they do not have access online. From this week, people aged 65 and over, pregnant […]

September 15, 2023

The US is currently experiencing a shortage of 15 cancer drugs as a result of manufacturing and supply chain issues. Three of these drugs – cisplatin, carboplatin and methotrexate – have been staples of cancer treatment for decades, but their […]

September 13, 2023

Advisers to the Food and Drug Administration on Wednesday endorsed Alnylam Pharmaceuticals’ drug Onpattro for a rare heart condition, despite questions from agency scientists over the degree of benefit offered by the RNA-based therapy. The advisory committee’s 9-3 vote sets […]

September 8, 2023

Lotronex (alosetron hydrochloride) and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea. Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, FDA has determined the […]

September 1, 2023

The Food and Drug Administration’s decision last month not to approve a new treatment for one of the most common forms of depression was, in part, due to safety concerns, according to newly released documents detailing the agency’s review process. […]

August 29, 2023

The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme Faron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its bexmarilimab for acute myeloid leukaemia […]

August 29, 2023

The Food and Drug Administration on Monday approved wider use of a drug important to Bristol Myers Squibb’s future, clearing the medicine for people newly diagnosed with a cancer-like disease of the bone marrow. Called Reblozyl, the drug has been […]

August 22, 2023

The FDA’s decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD in infants from birth until they are six months old. RSV […]

August 22, 2023

Women may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV), following U.S. Food and Drug Administration approval of the shot, called Abrysvo, on Monday The vaccine is designed […]

August 21, 2023

On Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a […]

August 17, 2023

The road to the U.S. market has been a winding one for Sohonos and Ipsen. Roche originally developed the medicine as a treatment for chronic obstructive pulmonary disease, but it failed in testing. The Canadian biotech Clementia Pharmaceuticals then licensed […]

August 17, 2023

The U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer. The approval makes Akeega the first and only dual action tablet combining a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor […]

August 16, 2023

The FDA’s decision to skip an advisory panel may indicate that agency reviewers are more unified in their views of the Bluebird therapy. Or it could simply indicate a higher comfort level with the type of treatment Bluebird is developing; […]

August 15, 2023

CAR-T therapies are engineered from patients’ own T cells to attack cancer. The process requires the cells to be withdrawn from patients’ bodies and manufactured into the treatment, a time lag that makes recipients vulnerable to disease progression in the […]

August 14, 2023

The Food and Drug Administration has delayed by three months its decision on what could be the first vaccine available in the U.S. for chikungunya virus. In an announcement Monday, French vaccine maker Valneva said the FDA extended an evaluation […]

August 14, 2023

As with other types of cancers, researchers have sought ways to turn the immune system against multiple myeloma. Their efforts have borne fruit with engineered T cell therapies like Bristol Myers Squibb and 2Seventy Bio’s Abecma and J&J and Legend […]

August 11, 2023

The success of cancer immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo kicked off a broad search by biopharmaceutical companies for other ways to turn the immune system against cancer. One strategy that drew interest was targeting a […]