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FDA Approves Pembrolizumab Plus Chemo With or Without Bevacizumab for Frontline Cervical Cancer
https://www.onclive.com/view/fda-approves-pembrolizumab-plus-chemo-with-or-without-bevacizumab-for-frontline-cervical-cancer

Oct 19th, 2021 - The FDA has approved pembrolizumab (Keytruda) for use in combination with chemotherapy, with or without bevacizumab (Avastin), in patients with persistent, recurrent or metastatic cervical cancer whose tumors have a PD-L1 combined positive score (CPS) of 1 or higher, as determined by an FDA-approved test.1 The regulatory agency also granted regular approval to pembrolizumab as a monotherapy in...

Front Runners in Development of Antibody Drugs Against COVID-19
https://www.medscape.com/viewarticle/960878

Oct 15th, 2021 - (Reuters) - AstraZeneca, Eli Lilly, Regeneron and GlaxoSmithKline are among the biggest players to have developed COVID-19 treatments using a class of drugs called monoclonal antibodies. Lab-made monoclonal antibodies mimic natural antibodies in fighting off infections. Unlike vaccines they do not rely on the body to create an immune response, and can therefore help individuals with weak or com...

Califf Eyed for Second Term as FDA Chief, News Reports Say
https://www.medscape.com/viewarticle/960980

Oct 15th, 2021 - The White House is considering an experienced leader to serve as the top US regulator of drugs and medical devices, with Robert Califf, MD, emerging as the likely pick, according to several major news organizations. The Washington Post reported at midday Thursday that President Joe Biden may tap Califf to serve again as Food and Drug Administration (FDA) commissioner, citing three people who sp...

FDA OKs Adjuvant Atezolizumab for Early-Stage Lung Cancer
https://www.medscape.com/viewarticle/960998

Oct 15th, 2021 - The US Food and Drug Administration has approved a new indication for the immunotherapy drug atezolizumab (Tecentriq) — the adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression ≥ 1%. The agency also approved the Ventana PD-L1 (SP263) Assay (Ventana Medical Systems) as the co...

European Agency Supports Marketing of Abrocitinib for Atopic Dermatitis
https://www.medscape.com/viewarticle/961004

Oct 15th, 2021 - The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended that the oral Janus kinase 1 inhibitor abrocitinib be granted marketing authorization in the European Union for treating atopic dermatitis (AD). The full indication is for the treatment of moderate to severe AD in adults who are candidates for systemic therapy, according to a summary of the opini...

FDA Panel Backs Second Shot for Those Who Got J&J Vaccine 
https://www.medscape.com/viewarticle/961003

Oct 15th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. A US Food and Drug Administration (FDA) advisory committee on Friday voted 19-0 to authorize second doses of the Johnson & Johnson COVID-19 vaccine in an effort to boost immunity. It was the second vote in as many days to back a change to a COVID vaccine timeline. In its vote, the committee said...

Pfizer COVID Vaccine Boosters: Who Needs Them? Who Can Get Them?
https://www.medscape.com/viewarticle/960815

Oct 15th, 2021 - This transcript has been edited for clarity. This is part 2 of a Medicine Matters series on "Battle for Boosters." This segment addresses Pfizer/BioNTech mRNA COVID vaccine boosters: Who needs them, and when? (Part 1 of this series, on third vaccine doses for the immunocompromised, can be found here.) Delta Is Dominant The Delta coronavirus variant now makes up more than 99% of new COVID cases....

FDA Advisors Vote to Recommend Moderna Boosters
https://www.medscape.com/viewarticle/960915

Oct 14th, 2021 - Editor's note: This story was updated Thursday October 14, 6:45 PM A panel of experts that advises the FDA on vaccine decisions voted unanimously Thursday to approve booster doses of Moderna's COVID-19 vaccine. The 19 members of the FDA's Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose — half the dose used in the primary series of shots — to bo...

Lupin Recalls Irbesartan and Hydrochlorothiazide/Irbesartan Tablets
https://www.medscape.com/viewarticle/960937

Oct 14th, 2021 - Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity. "As part of Lupin's ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not f...

Mixing COVID Vaccine Boosters May Be Better Option: Study
https://www.medscape.com/viewarticle/960932

Oct 14th, 2021 - A new US government study shows it isn't risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose. The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had. If regulators endorse the...

US FDA Removes Concessions on Hand Sanitizer Production as Supply Recovers
https://www.medscape.com/viewarticle/960715

Oct 13th, 2021 - (Reuters) - The U.S. Food and Drug Administration said on Tuesday companies manufacturing certain alcohol-based hand sanitizers under its previous relaxed guidance must stop making these products by the end of the year as there is no longer a shortage. The FDA had issued the temporary guidelines in March 2020 to address tight supply conditions for sanitizers, driven by a surge in demand for the...

US FDA Gives Marketing Nod to an e-Cigarette for the First Time
https://www.medscape.com/viewarticle/960766

Oct 13th, 2021 - (Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday allowed British American Tobacco Plc (BAT) to market its Vuse Solo e-cigarettes and tobacco-flavored pods, making it the first-ever vapor product to get clearance from the health regulator. The FDA said the approval came after analysis of data from the manufacturer that showed that using Vuse's tobacco-flavored products could he...

New FDA Guidance Aims to Cut Sodium in Processed Foods
https://www.medscape.com/viewarticle/960788

Oct 13th, 2021 - The US Food and Drug Administration (FDA) has issued voluntary, short-term sodium reduction targets for food manufacturers, chain restaurants, and food service operators for processed, packaged, and prepared foods, with an eye toward reducing diet-related conditions such as heart disease and obesity. According to the FDA, more than 70% of total sodium intake is from sodium added during food man...

FDA Questions Reliability of Data Backing J & J's Bid for Boosters
https://www.medscape.com/viewarticle/960825

Oct 13th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The US Food and Drug Administration (FDA) said Johnson & Johnson may have to put its thumb on the scale when making its case to an advisory panel on Friday to market boosters for its single-dose vaccine. Johnson & Johnson, together with its partner Janssen, has asked the FDA to authorize a secon...

FDA OKs Gender-Neutral Language for Isotretinoin iPLEDGE Risk Management Program
https://www.medscape.com/viewarticle/960804

Oct 13th, 2021 - The Food and Drug Administration has approved a modification to the isotretinoin risk-mitigation program to make it more inclusive for transgender patients. Beginning on Dec. 13, 2021, patients prescribed isotretinoin for acne will be assigned to one of two risk categories — those who can get pregnant and those who cannot for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). Previousl...

FDA Approves Pembrolizumab Plus Chemo as First-Line Therapy for Advanced, Recurrent Cervical Cancer
https://www.medscape.com/viewarticle/960819

Oct 13th, 2021 - The US Food and Drug Administration (FDA) has approved the checkpoint inhibitor pembrolizumab (Keytruda, Merck) alongside standard chemotherapy — with or without bevacizumab — as first-line therapy for patients with persistent, recurrent, or metastatic PD-L1-expressing cervical cancer. The first-line approval comes on the heels of the phase 3 results from the KEYNOTE-826 trial, presented last m...

FDA Approves Cetuximab Plus Encorafenib for BRAF V600E–Mutant Metastatic CRC After Prior Therapy
https://www.onclive.com/view/fda-approves-cetuximab-plus-encorafenib-for-braf-v600e-mutant-metastatic-crc-after-prior-therapy

Oct 12th, 2021 - The FDA has granted approval of a new indication for cetuximab (Erbitux) plus encorafenib (Braftovi) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by a FDA-approved test, after prior therapy.1 Cetuximab is the first and only anti-EGFR antibody with regulatory approval, in combination with encorafenib, for this indication, ac...

FDA Lifts Hold on Rusfertide Clinical Development Program
https://www.onclive.com/view/fda-lifts-hold-on-rusfertide-clinical-development-program

Oct 12th, 2021 - The FDA has removed the full clinical hold that had previously been placed on trials evaluating rusfertide (PTG-300), according to an announcement from Protagonist Therapeutics, Inc.1 With this decision, dosing on all studies evaluating the agent is permitted to resume. The regulatory agency placed the hold on the trials in September 2021 following a notification from the pharmaceutical comp...

FDA Issued Postmarket CVD Safety Warning for 1 in 4 Cancer Drugs
https://www.medscape.com/viewarticle/960685

Oct 12th, 2021 - The US Food and Drug Administration (FDA) has issued postmarket cardiac safety warnings for about 1 in 4 cancer therapies, according to a research letter published September 30 in JAMA Oncology. These cardiotoxic risk communications typically were issued just over 4.5 years after a drug's approval — 40% longer than it took to issue noncardiac warnings. However, lead author Daniel Addison, MD, e...

Some Cord-Blood Products Marketed as Stem Cell Therapies Tainted With Bacteria
https://www.medscape.com/viewarticle/960494

Oct 11th, 2021 - NEW YORK (Reuters Health) - Cord-blood-derived products marketed for treatments that the U.S. Food and Drug Administration (FDA) has not approved may be contaminated with bacteria, a new government study shows. In an investigation of bacterial infections in 20 patients who received products made from umbilical cord blood and marketed as stem-cell treatments, researchers found that not only have...