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Tag: 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 […]


Pricing, Regulations

AstraZeneca’s drug pricing lawsuit dismissed by federal judge

March 4, 2024

Via: Biopharma Dive

For the second time in less than a month, a federal court has rejected a pharmaceutical industry lawsuit challenging the drug pricing powers Medicare was granted by the Inflation Reduction Act. The U.S. District Court for the District of Delaware […]


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 […]


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]


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 […]


Cell and Gene Therapy, Industry

Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations

February 27, 2024

Via: World Pharma News

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, […]


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 […]


News

UK biotech Curve swings £40.5m in Pfizer-backed round

February 27, 2024

Via: Pharmaphorum

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]


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

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 […]


Cell and Gene Therapy, Industry

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

Via: Biopharm International

On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously […]


Clinical Trials, Research and Development

New initiative to improve patient retention in paediatric clinical trials

February 20, 2024

Via: Pharma Times

Innovative Trials has announced a new initiative designed to boost clinical trial patient retention in paediatric studies, in partnership with the Oliver Patch Project, a US charity. The Retention Patch Program is designed to engage directly with children and young […]


News

FDA starts review of Argenx drug in rare disease CIDP

February 20, 2024

Via: Pharmaphorum

If approved, Vyvgart Hytrulo (efgartigimod alfa) will be the first drug in the FcRn blocker class to treat CIDP, a rare autoimmune disease of the peripheral nervous system that causes fatigue, muscle weakness, and loss of feeling that can lead […]


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) […]


News

First drug therapy for frostbite has been cleared by FDA

February 15, 2024

Via: Pharmaphorum

The US regulator has cleared Aurlumyn (iloprost) injection from CiVi Biopharma subsidiary Eicos Sciences as a treatment for severe frostbite, caused by prolonged exposure to extreme cold, after a priority review. The incidence of severe frostbite injury in the US […]