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Category: Regulations


FDA, Regulations

FDA Advisors Support New Alzheimer’s Drug, Donanemab

June 11, 2024

Via: Drugs.com

A U.S. Food and Drug Administration advisory panel voted unanimously on Monday to recommend that the benefits of a new drug for Alzheimer’s outweigh its harms, which can include brain swelling and bleeding. Eli Lilly’s donanemab did slow declines in thinking skills […]


FDA, Industry, Regulations, Vaccines

FDA Gives Nod to RSV Vaccine for People in Their 50s

June 10, 2024

Via: Drugs.com

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness. Drugmaker GSK’s Arexvy vaccine, […]


FDA, Regulations

FDA OKs wider use of Almirall’s actinic keratosis drug

June 10, 2024

Via: Pharmaphorum

First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can […]


FDA, Regulations

FDA Rescinds Ban on Juul E-Cigarettes

June 7, 2024

Via: Drugs.com

A ban on Juul e-cigarettes has been reversed, the U.S. Food and Drug Administration announced Thursday. Why? The agency said it needs to review both new court decisions and updated data from the vape maker. While the company’s e-cigarettes are […]


FDA, Regulations

With Bird Flu a Threat, FDA Asks Some States to Curb Sales of Raw Milk

June 7, 2024

Via: Drugs.com

The U.S. Food and Drug Administration on Thursday asked states to work harder to protect the public from the risks of raw milk as a bird flu outbreak continues to spread among dairy cows. In an open letter to state […]


FDA, Industry, Regulations, Vaccines

FDA advisers back updating COVID shots to target JN.1 virus family

June 6, 2024

Via: Biopharma Dive

A group of advisers to the Food and Drug Administration on Wednesday unanimously recommended that COVID-19 vaccines be updated to cover coronavirus strains with a family known as JN.1 ahead of the fall. The committee, which had originally been scheduled […]


FDA, Regulations

FDA Panel Says No to MDMA as Treatment for PTSD

June 5, 2024

Via: Drugs.com

A U.S. Food and Drug Administration advisory panel on Tuesday voted against recommending the psychedelic MDMA for the treatment of post-traumatic stress disorder (PTSD). In a 10-1 vote, the panel determined the evidence amassed so far fails to show the […]


FDA, Regulations

Bristol Myers Squibb’s Breyanzi receives FDA approval for mantle cell lymphoma

June 3, 2024

Via: PMLiVE

Representing around 3% of all non-Hodgkin lymphoma (NHL) cases, MCL is a rare form of NHL that originates from cells in the mantle zone of the lymph node. For most patients, relapse after initial treatment is common and the disease […]


FDA, Industry, Regulations, Vaccines

Moderna wins FDA approval for RSV vaccine

May 31, 2024

Via: Biopharma Dive

The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer. The vaccine, dubbed mResvia, is […]


FDA, Regulations

FDA sets date for Sarclisa in first-line multiple myeloma

May 28, 2024

Via: Pharmaphorum

The French pharma group has filed anti-CD38 antibody Sarclisa (isatuximab) for use in combination with Takeda’s Velcade (bortezomib), lenalidomide, and dexamethasone – known as the VRd regimen – in previously untreated multiple myeloma patients who are not eligible for or […]


Pricing, Regulations

High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment

May 21, 2024

Via: Kaiser Health News

For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill their prescriptions for the medications they need to control their blood sugar. Without Ozempic or a similar drug, […]


FDA, Regulations

Sanofi and Sobi’s Altuviiio label updated by FDA with expanded paediatric data in haemophilia A

May 20, 2024

Via: PMLiVE

Haemophilia A is a rare hereditary bleeding disorder that occurs when there is a lack of sufficient functioning factor VIII protein to help the blood clot, leading to external bleeding, bruising and bleeding into joints. Designed to extend protection from […]


FDA, Regulations

Biogen and Eisai announce rolling FDA submission for injectable version of Alzheimer’s drug

May 15, 2024

Via: PMLiVE

Leqembi (lecanemab-irmb) was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage Alzheimer’s disease. The Leqembi SC autoinjector has already been granted Fast Track designation […]


FDA, Industry, Regulations, Vaccines

FDA delays decision on Moderna’s RSV vaccine

May 13, 2024

Via: Pharmaphorum

The company said the FDA would not be able to complete its review of the mRNA-1345 vaccine by the scheduled date of 12th May due to “administrative constraints”, causing nervousness among investors that led to a near-3% decline in its […]


FDA, Regulations

FDA Issues New Draft Guidance on Allogeneic Cell-Based Medical Products

May 1, 2024

Via: Biopharm International

FDA has announced a new draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The document was issued in April 2024 by the agency’s Center for Biologics Evaluation and Research (CBER) (1). According […]


Clinical Trials, FDA, Regulations, Research and Development

Novartis’ Lutathera receives FDA approval to treat neuroendocrine tumours in paediatric patients

April 25, 2024

Via: PMLiVE

Patients eligible for the therapy will be aged 12 years and older and have somatostatin receptor (SSTR)-positive gastroenteropancreatic NETs, including foregut, midgut and hindgut NETs. The FDA’s decision was supported by positive results from the NETTER-P trial, which evaluated Lutathera […]


Cell and Gene Therapy, FDA, Industry, Regulations

FDA rejects Abeona cell therapy, asks for more manufacturing data

April 23, 2024

Via: Biopharma Dive

The Food and Drug Administration has rejected an experimental cell therapy for a rare skin condition, asking its developer, Abeona Therapeutics, to provide more information about how the treatment is made. Abeona on Monday said the FDA issued a so-called […]


FDA, Regulations

FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

April 23, 2024

Via: Pharmaphorum

Anktiva (nogapendekin alfa inbakicep, or N-803) can be used in combination with the BCG vaccine in non-muscle invasive bladder cancer (NMIBC) patients who had not responded to the BCG shot on its own, according to the FDA, which blocked the […]


FDA, Regulations

Stelara biosimilar from Alvotech, Teva approved by FDA

April 17, 2024

Via: Biopharma Dive

Stelara is one of many top-selling medicines that will face competition from copycat versions this decade, including a large number of biologic drugs. AbbVie’s anti-inflammatory medicine Humira — sales of which topped $21 billion in 2022 — has been a […]


FDA, Regulations

AstraZeneca’s Fasenra receives FDA approval for paediatric patients with severe asthma

April 15, 2024

Via: PMLiVE

The approval was based on evidence from the open-label phase 3 TATE trial in addition to well-controlled trials in adult and adolescent populations. Asthma is one of the most common chronic childhood diseases and causes coughing, wheezing and difficulty breathing. […]