FDA - Drug Discovery Digest

FDA Limits COVID-19 Boosters to Seniors, Other High-Risk Groups

Drugs.com

MAY 21, 2025

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.

FDA

FDA Drugs

FDA to Review and Possibly Ban Fluoride Supplements for Kids

Drugs.com

MAY 14, 2025

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.

FDA

FDA Drugs

FDA OKs first blood test to aid Alzheimer’s diagnosis

BioPharma Drive: Drug Pricing

MAY 19, 2025

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.

FDA

FDA Disease

Moderna's New Lower-Dose COVID-19 Vaccine, mNexspike, Approved by FDA

Drugs.com

JUNE 3, 2025

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.

Vaccine

Vaccine FDA Drugs

FDA meeting gives window into gene therapy field’s angst

BioPharma Drive: Drug Pricing

JUNE 6, 2025

Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.

Therapies

Therapies FDA

Pfizer names Patrizia Cavazzoni, former top FDA official, as chief medical officer

BioPharma Drive: Drug Pricing

FEBRUARY 24, 2025

Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.

FDA

FDA Drugs

Novavax COVID Vaccine Moves Closer to Full FDA Approval

Drugs.com

APRIL 25, 2025

Food and Drug Administration (FDA), the company said Wednesday.The update sent Novavaxs stock up more than 21% in early trading. FRIDAY, April 25, 2025 Novavaxs COVID-19 vaccine could soon receive full approval from the U.S. It also helped ease.

FDA Approval

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FDA delays approval decision for Biohaven rare disease drug

BioPharma Drive: Drug Pricing

MAY 15, 2025

Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an outside group of advisers to evaluate it as well.

FDA

FDA Disease Drugs

Duchenne approval exposes FDA rift over Sarepta gene therapy

BioPharma Drive: Drug Pricing

JUNE 21, 2024

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

Therapies

Therapies FDA

FDA Warns of Toxic Lead in Cinnamon Products

Drugs.com

MARCH 6, 2024

The FDA urged folks to throw away and not buy the following brands of. WEDNESDAY, March 6, 2024 -- The U.S. Food and Drug Administration issued a health advisory Wednesday warning consumers that six brands of ground cinnamon are tainted with lead.

FDA

FDA Production Drugs

FDA Launches Postmarket Chemical Review Program to Ensure Food Safety

Drugs.com

MAY 19, 2025

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

FDA Drugs

Patrizia Cavazzoni, key FDA official, to leave agency

BioPharma Drive: Drug Pricing

JANUARY 10, 2025

The director of the FDA's main drug review office will exit on Jan. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change. 18, according to an email sent to staff.

FDA

FDA Drugs

FDA makes end of Zepbound, Mounjaro shortage official

BioPharma Drive: Drug Pricing

OCTOBER 3, 2024

Removal of Lilly’s in-demand drugs from the FDA’s shortage list ramps up pressure on the companies selling compounded versions.

FDA

FDA Drugs

FDA Approves Susvimo for Diabetic Macular Edema

Drugs.com

FEBRUARY 5, 2025

Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema.Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with diabetic. WEDNESDAY, Feb. 5, 2025 -- The U.S.

FDA Approval

FDA Approval FDA Treatment Drugs

FDA Warns of Counterfeit Ozempic

Drugs.com

DECEMBER 22, 2023

The FDA said Thursday that it has seized thousands of. FRIDAY, Dec. 22, 2023 -- The U.S. Food and Drug Administration has uncovered counterfeit Ozempic shots in the legitimate U.S. drug supply chain, and is warning patients to be on their guard.

FDA

FDA Drugs

Zepbound, Mounjaro shortages are resolved, FDA confirms

BioPharma Drive: Drug Pricing

DECEMBER 19, 2024

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

Compounding Pharmacies

Compounding Pharmacies FDA Pharmacy Marketing

Vertex, CRISPR therapy for sickle cell passes FDA panel test

BioPharma Drive: Drug Pricing

OCTOBER 31, 2023

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

FDA

FDA Therapies Treatment

CRISPR therapy for sickle cell approved by FDA in gene editing milestone

BioPharma Drive: Drug Pricing

DECEMBER 8, 2023

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

FDA

FDA Therapies Pharmaceuticals Treatment

FDA Approves Another Blood Test for Colon Cancer Screening

Drugs.com

JULY 29, 2024

late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S. Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In

FDA Approval

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FDA Delays Final Approval of Novavax COVID Vaccine

Drugs.com

APRIL 4, 2025

Food and Drug Administration (FDA) has delayed the full approval of Novavaxs COVID-19 vaccine. FRIDAY, April 4, 2025 -- The U.S. The decision had been expected by April 1, but the agency now says it needs more information before moving forward.The.

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Vaccine FDA Drugs

FDA OKs Amvuttra To Treat Heart Conditions

Drugs.com

MARCH 24, 2025

Food and Drug Administration (FDA) has approved a new drug for a serious heart condition that affects thousands of people. MONDAY, March 24, 2025 -- The U.S. The drug, called Amvuttra (vutrisiran), is made by Alnylam Pharmaceuticals and is used to.

FDA

FDA Pharmaceuticals Drugs

FDA Approves Journavx, First New Non-Opioid Pain Pill in Decades

Drugs.com

JANUARY 31, 2025

Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin. FRIDAY, Jan. 31, 2025 -- The U.S. The new pill, developed by Vertex.

FDA Approval

FDA Approval FDA Drugs

Verve gets FDA green light to run base editing study in US

BioPharma Drive: Drug Pricing

OCTOBER 23, 2023

since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease. The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S.

FDA

FDA Trials Treatment Disease

FDA OK's Ozempic To Protect Kidneys in Type 2 Diabetes Patients

Drugs.com

JANUARY 29, 2025

Food and Drug Administration (FDA) has officially approved Ozempic to. WEDNESDAY, Jan. 29, 2025 -- A popular diabetes drug just got a major new approval -- and it could be a game-changer for millions of Americans at risk for kidney failure.

FDA

FDA Drugs

FDA Warns of Accidental Overdoses from Compounded Versions of Ozempic

Drugs.com

JULY 30, 2024

Food and Drug Administration warns.These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA. TUESDAY, July 30, 2024 -- People taking compounded versions of Ozempic have been overdosing on the drug, the U.S.

FDA

FDA Drugs

FDA plans to phase out animal testing for some drugs

BioPharma Drive: Drug Pricing

APRIL 11, 2025

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

Animal Testing

Animal Testing FDA Drugs

FDA meeting on flu vaccine composition is canceled

BioPharma Drive: Drug Pricing

FEBRUARY 27, 2025

The meeting, which helps the FDA give guidance to vaccine makers on which flu strains to target, is the second to be disrupted since Robert F. Kennedy Jr. was sworn in as health secretary.

Vaccine

Vaccine FDA

5 FDA decisions to watch in the second quarter

BioPharma Drive: Drug Pricing

APRIL 1, 2024

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

FDA

FDA Therapies

Proposed FDA Rule Targets Asbestos in Talc Cosmetic Products

Drugs.com

DECEMBER 27, 2024

Food and Drug Administration (FDA) has proposed a new rule to require standardized testing of talc-containing cosmetics for asbestos, a known carcinogen linked to serious illnesses such as lung and ovarian. FRIDAY, Dec. 27, 2024 -- The U.S.

FDA

FDA Production Drugs

FDA Warns of Danger From At-Home Chemical Peels

Drugs.com

AUGUST 1, 2024

FDA is warning consumers not to purchase or use. THURSDAY, Aug. 1, 2024 -- Don't use a chemical peel to help rejuvenate your skin unless it's done under the supervision of a trained professional, the U.S. Food and Drug Administration has advised.

FDA

FDA Drugs

Top FDA Vaccine Official Quits, Warns of Vaccine Misinformation

Drugs.com

MARCH 31, 2025

Food and Drug Administration (FDA) is stepping down, warning that vaccine misinformation is coloring the countrys top health decisions.Dr. Peter Marks, director of the FDAs Center for Bi. MONDAY, March 31, 2025 -- A top vaccine official at the U.S.

Vaccine

Vaccine FDA Drugs

In FDA job cuts, experts see threat of far-reaching impact

BioPharma Drive: Drug Pricing

FEBRUARY 20, 2025

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency commissioner Robert Califf.

FDA

FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA

FDA FDA Approval Clinical Trials Therapies

FDA cuts outlined in draft HHS budget

BioPharma Drive: Drug Pricing

APRIL 18, 2025

The leaked budget draft, if approved by Congress, would reduce the FDA’s budget authority, indicating more disruption could be in store for an agency already shaken by large-scale layoffs.

FDA

FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

FDA

FDA Regulations International Drugs

FDA to use new review tool on Sarepta’s gene therapy work

BioPharma Drive: Drug Pricing

JUNE 4, 2025

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene therapy applications it later brings to the regulator.

Therapies

Therapies FDA Regulations

Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use

BioPharma Drive: Drug Pricing

APRIL 5, 2024

The FDA’s clearance comes three weeks after a panel of advisers endorsed expanded use of Abecma despite safety concerns raised by the agency.

FDA

FDA Therapies

FDA official’s ouster sends shares of vaccine makers sliding

BioPharma Drive: Drug Pricing

MARCH 31, 2025

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

Vaccine

Vaccine FDA

Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food

Drugs.com

JANUARY 7, 2025

Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this week. TUESDAY, Jan. 7, 2025 -- The U.S. However, many health and safety advocates say they are not satisfied with the guidance.Under.

FDA

FDA Drugs

FDA sets stricter approval standards for COVID vaccines

BioPharma Drive: Drug Pricing

MAY 20, 2025

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

Vaccine

Vaccine FDA

FDA Proposes New Front-of-Package Food Labels

Drugs.com

JANUARY 15, 2025

Food and Drug Administration (FDA) has proposed a new rule requiring bold, easy-to-read nutrition labels on the front of food and beverage. WEDNESDAY, Jan. 15, 2025 -- Grabbing a quick snack might soon come with a little extra clarity.

Packaging

Packaging FDA Drugs

Sara Brenner, FDA device official, named agency’s acting head

BioPharma Drive: Drug Pricing

JANUARY 24, 2025

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

FDA

FDA Proposes Nicotine Cap To Help Curb Cigarette Addiction

Drugs.com

JANUARY 16, 2025

Food and Drug Administration (FDA) proposal aims to make cigarettes and other tobacco products far less addictive by reducing their nicotine content.The move could help millions of Americans quit. THURSDAY, Jan. 16, 2025 -- A rather historic U.S.

FDA

FDA Production Drugs

FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots

BioPharma Drive: Drug Pricing

MAY 27, 2025

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.

Vaccine

Vaccine FDA

FDA Limits COVID-19 Boosters to Seniors, Other High-Risk Groups

FDA to Review and Possibly Ban Fluoride Supplements for Kids

Trending Sources

FDA OKs first blood test to aid Alzheimer’s diagnosis

Moderna's New Lower-Dose COVID-19 Vaccine, mNexspike, Approved by FDA

FDA meeting gives window into gene therapy field’s angst

Pfizer names Patrizia Cavazzoni, former top FDA official, as chief medical officer

Novavax COVID Vaccine Moves Closer to Full FDA Approval

FDA delays approval decision for Biohaven rare disease drug

Duchenne approval exposes FDA rift over Sarepta gene therapy

FDA Warns of Toxic Lead in Cinnamon Products

FDA Launches Postmarket Chemical Review Program to Ensure Food Safety

Patrizia Cavazzoni, key FDA official, to leave agency

FDA makes end of Zepbound, Mounjaro shortage official

FDA Approves Susvimo for Diabetic Macular Edema

FDA Warns of Counterfeit Ozempic

Zepbound, Mounjaro shortages are resolved, FDA confirms

Vertex, CRISPR therapy for sickle cell passes FDA panel test

CRISPR therapy for sickle cell approved by FDA in gene editing milestone

FDA Approves Another Blood Test for Colon Cancer Screening

FDA Delays Final Approval of Novavax COVID Vaccine

FDA OKs Amvuttra To Treat Heart Conditions

FDA Approves Journavx, First New Non-Opioid Pain Pill in Decades

Verve gets FDA green light to run base editing study in US

FDA OK's Ozempic To Protect Kidneys in Type 2 Diabetes Patients

FDA Warns of Accidental Overdoses from Compounded Versions of Ozempic

FDA plans to phase out animal testing for some drugs

FDA meeting on flu vaccine composition is canceled

5 FDA decisions to watch in the second quarter

Proposed FDA Rule Targets Asbestos in Talc Cosmetic Products

FDA Warns of Danger From At-Home Chemical Peels

Top FDA Vaccine Official Quits, Warns of Vaccine Misinformation

In FDA job cuts, experts see threat of far-reaching impact

FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

FDA cuts outlined in draft HHS budget

FDA Inspections: Lesson 1 – Interviewing Employees

FDA to use new review tool on Sarepta’s gene therapy work

Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use

FDA official’s ouster sends shares of vaccine makers sliding

Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food

FDA sets stricter approval standards for COVID vaccines

FDA Proposes New Front-of-Package Food Labels

Sara Brenner, FDA device official, named agency’s acting head

FDA Proposes Nicotine Cap To Help Curb Cigarette Addiction

FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots

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