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Category: FDA


FDA, Regulations

FDA Releases Facility Readiness Guidance

June 21, 2024

Via: Biopharm International

FDA published a final guidance document on June 18, 2024 that provides applicants with information on FDA’s policy for assigning a goal date for a facility’s inspection readiness as certified on Form FDA 356h, submitted as part of an original […]


Cell and Gene Therapy, FDA, Industry, Regulations

Sarepta Duchenne gene therapy wins broader use from FDA

June 20, 2024

Via: Biopharma Dive

The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness. The agency on Thursday made the therapy, called […]


FDA, Regulations

AbbVie’s IL-23 inhibitor Skyrizi approved by FDA to treat ulcerative colitis in adults

June 19, 2024

Via: PMLiVE

Affecting more than one million people in the US, UC is a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of […]


FDA, Regulations

FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

June 18, 2024

Via: Biopharm International

Global healthcare company, Grifols, announced on June 17, 2024 that its subsidiary Biotest has garnered its first FDA approval with the intravenous immunoglobulin (Ig) therapeutic, Yimmugo, which Grifols hopes to launch commercially in the United States in the second half […]


FDA, Regulations

FDA clears Roche digital pathology platform for diagnosis

June 18, 2024

Via: Pharmaphorum

The clearance covers Roche’s Ventana DP 200 slide scanner, digital pathology workflow software, and a display that can be used to review and interpret digital images of scanned pathology slides. Proponents of digital pathology technologies say that having this image data in […]


FDA, Regulations

Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication

June 17, 2024

Via: PMLiVE

The therapy has been authorised for use in patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. With more than 6,500 new cases diagnosed in the US […]


FDA, Industry, Regulations, Vaccines

FDA Tells Vaccine Makers to Target New COVID Variant for Fall

June 14, 2024

Via: Drugs.com

COVID vaccine makers will be advised to update their shots to target the KP.2 variant, an offshoot of the JN.1 variant that spread widely last winter, the U.S. Food and Drug Administration announced Thursday. It’s a turnaround for the agency: […]


FDA, Regulations

FDA widens label for BMS’ cancer drug Augtyro

June 14, 2024

Via: Pharmaphorum

Augtyro (repotrectinib), which first got a green light from the FDA as a treatment for ROS1-positive non-small-cell lung cancer (NSCLC) last November, has now had its label extended to include all solid tumours that have NTRK gene fusions. The NSCLC approval was […]


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 […]


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 […]