This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Food and Drug Administration (FDA) has upgraded a recall of a commonly prescribed thyroid medication due to what it described as "subpotent" active ingredients. THURSDAY, July 24, 2025 — The U.S. The recall of more than 160,000 bottles of.
Food and Drug Administration has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.The combination pill is the first and only FDA-approved triple combination.
Food and Drug Administration (FDA) has decided that only seniors and people at high risk should get the latest COVID-19 booster shots this fall.The new framework, announced Tuesday, says adults 65 and older, and p. WEDNESDAY May 21, 2025 The U.S.
Food and Drug Administration (FDA) plans to review and possibly remove prescription fluoride supplements for children from the market.The FDA announced Tuesday that it intends to conduct the review by Oct. WEDNESDAY, May 14, 2025 The U.S.
Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic hand eczema (CHE). THURSDAY, July 24, 2025 — The U.S. CHE is common condition marked by redness, itching and cracking on the.
A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.
Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.
Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection. FRIDAY, June 20, 2025 — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year. On Wednesday, the U.S.
MONDAY, July 21, 2025 -- The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster). The existing vaccine consists of two.
A slower ramp-up of Kisunla dosing lowers the rate of dangerous brain swelling, a risk that has made doctors reluctant to prescribe Lilly’s amyloid-busting drug.
The FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.
The study examines the frequency, distribution, prevalence, and diversity of oxygen atoms in a dataset of 2049 small molecules approved by the FDA and other agencies. This work presents a comprehensive analysis of oxygen atoms in approved drugs, aiming to streamline drug design and discovery efforts.
Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection that was shown to. FRIDAY, June 20, 2025 — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year.On Wednesday, the U.S.
The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.
Food and Drug Administration (FDA) has approved a monoclonal. THURSDAY, June 12, 2025 — A newly approved shot could soon help protect babies from respiratory syncytial virus (RSV), the top cause of hospitalization in U.S.
Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of new drugs and medical devices. WEDNESDAY, June 11, 2025 — The U.S. That's one of several priorities federal officials detailed.
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the agency during deramiocel’s review.
FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,
Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. Thats all bad news if your timeline depends on FDA sticking to theirs. By John W.M. Claud & Michelle L.
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving medicines that it later cleared.
FRIDAY, June 20, 2025 -- The U.S. Food and Drug Administration has approved Andembry (garadacimab-gxii) as the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE). According to the Mayo.
Food and Drug Administration (FDA) later this month. FRIDAY, June 6, 2025 — A new injection to prevent HIV is expected to be approved by the U.S. If approved, the shot — lenacapavir — would be given twice a year and could be a big.
Regulatory expert shares how early planning and FDA engagement can speed oncology approval For biotech companies advancing oncology therapies, regulatory speed can be critical to achieving key milestones and getting new therapies to patients faster.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.
TUESDAY, June 3, 2025 -- The U.S. Food and Drug Administration has approved a new lower-dose vaccine for active immunization against COVID-19 caused by severe acute respiratory syndrome coronavirus 2. The new vaccine (mNexspike [COVID-19 Vaccine.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment In a significant regulatory development, Bristol Myers Squibb announced that the U.S.
MONDAY, May 19, 2025 -- Last week, the U.S. Food and Drug Administration announced a move to improve transparency and strengthen the safety of chemicals used in the nation's food supply.The agency is implementing an enhanced review process for food.
FDA Approves Label Update for Lilly’s Amyvid, Expanding Its Role in Alzheimer’s Disease Diagnosis and Therapy Guidance In a major development for Alzheimer’s diagnostics, Eli Lilly and Company (NYSE: LLY) announced that the U.S. At the time, its use was primarily restricted to supporting the diagnostic process.
MONDAY, June 30, 2025 -- The U.S. Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy. Benlysta.
The company worked closely with agencies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) from the outset, aligning its methodology with evolving guidance. The FDA has also confirmed that Unlearn’s covariate adjustment strategy is consistent with current guidance.
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have become more difficult after the negative advisory committee vote.
Recent drug discovery efforts culminating from work during the past decade have resulted in two FDA-approved inhibitors, sotorasib and adagrasib, which target the KRASG12C mutant allele. Ongoing medicinal chemistry efforts across academia and industry have continued developing more potent and efficacious KRASG12C inhibitors.
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).
It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies. To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing.
The agency recommends manufacturers update their vaccines to target the JN.1 At the same time, HHS head Robert F. Kennedy Jr. is removing guidance that healthy children and pregnant women receive COVID shots.
Here, we demonstrate the utility of a high-throughput in vitro screening platform along with a comprehensive panel to aid in the characterization of 15 Brutons tyrosine kinase (BTK) inhibitors that are either approved by the FDA or presently under clinical evaluation.
Oncology drug approvals in H1 2025 In the first half of 2025, the FDA’s Center for Drug Evaluation and Research (CDER) approved a total of 16 novel drugs , with half of these drugs related to the treatment of cancer.
June 27, 2025 -- The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell.
New approach methodologies data In April, the US Food and Drug Administration (FDA) announced a plan to replace animal testing in the development of monoclonal antibodies and other therapies with validated “human-relevant” methods, including AI-based computational models evaluating toxicity, cellular lines and organoid toxicity.
The presence of thienopyrimidine derivatives in several FDA-approved drugs and clinical trial candidates underscores their therapeutic potential and safety profile. The review elaborates on the primary approach for synthesis of thienopyrimidines, using thiophene derivatives or pyrimidine analogues.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content