FDA - Drug Discovery Digest

FDA Upgrades Recall on 160,000+ Bottles of Thyroid Medication

Drugs.com

JULY 24, 2025

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.

FDA

FDA Drugs

FDA Approves Polypill Widaplik for Hypertension

Drugs.com

JUNE 11, 2025

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.

FDA Approval

FDA Approval FDA Treatment Drugs

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 Approves First Cream for Treating Chronic Hand Eczema, Anzupgo

Drugs.com

JULY 24, 2025

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.

FDA Approval

FDA Approval FDA Drugs

FDA to speed reviews for drugs supporting ‘national interests’

BioPharma Drive: Drug Pricing

JUNE 18, 2025

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.

FDA

FDA Drugs Production

After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder

BioPharma Drive: Drug Pricing

JULY 7, 2025

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an on-time approval.

FDA

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

FDA Approves First Twice-a-Year HIV Prevention Shot, Yeztugo

Drugs.com

JUNE 20, 2025

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.

FDA Approval

FDA Approval FDA Drugs

FDA Approves Prefilled Syringe Presentation for Shingles Vaccine

Drugs.com

JULY 21, 2025

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.

Vaccine

Vaccine FDA Approval FDA Drugs

Lilly gets FDA OK of modified dosing for Alzheimer’s drug

BioPharma Drive: Drug Pricing

JULY 9, 2025

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.

Doctors

Doctors 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

Analyzing Oxygen Atom Distribution in FDA‐Approved Drugs to Enhance Drug Discovery Strategies

Chemical Biology and Drug Design

FEBRUARY 6, 2025

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.

FDA Approval

FDA Approval FDA Small Molecule Pharmacokinetics

FDA Approves First Twice-a-Year HIV Prevention Shot

Drugs.com

JUNE 20, 2025

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.

FDA Approval

FDA Approval FDA Drugs

FDA approves twice-yearly shot of Gilead drug for HIV prevention

BioPharma Drive: Drug Pricing

JUNE 18, 2025

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.

FDA Approval

FDA Approval FDA Marketing Drugs

New Antibody Shot, Enflonsia, Could Help Protect Babies From RSV

Drugs.com

JUNE 12, 2025

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.

Virus

Virus Hospitals FDA Drugs

FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews

Drugs.com

JUNE 11, 2025

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.

FDA

FDA Drugs

FDA turns back Capricor’s Duchenne cell therapy

BioPharma Drive: Drug Pricing

JULY 11, 2025

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.

Therapies

Therapies FDA

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

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.,

FDA

FDA Trials Disease Drugs

Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Drug Discovery

APRIL 21, 2025

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.

FDA

FDA Drug Development Drugs International

FDA, in policy shift, publishes some drug rejection letters

BioPharma Drive: Drug Pricing

JULY 10, 2025

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.

FDA

FDA Drugs

FDA Approves Once-Monthly Andembry for Hereditary Angioedema

Drugs.com

JUNE 20, 2025

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.

FDA Approval

FDA Approval FDA Treatment Drugs

Long-Lasting HIV Prevention Shot Headed Toward Approval

Drugs.com

JUNE 6, 2025

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.

FDA

FDA Drugs

FDA Pathways Offer Faster Track for Oncology Drug Development

Fierce BioTech

JULY 15, 2025

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.

FDA

FDA Drug Development Therapies Drugs

Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

JULY 9, 2025

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.

Drugs

Drugs Clinical Development Therapies Clinical Trials

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

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

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.

Clinical Development

Clinical Development Production Clinical Trials Treatment

FDA Approves Label Updates for Bristol Myers Squibb Cell Therapies, Removes REMS

The Pharma Data

JUNE 26, 2025

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.

FDA Approval

FDA Approval Therapies FDA Treatment

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

Lilly’s Amyvid Receives FDA Label Revision to Support Alzheimer’s Diagnosis

The Pharma Data

JUNE 25, 2025

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.

FDA

FDA FDA Approval Therapies Disease

FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis

Drugs.com

JUNE 30, 2025

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.

FDA Approval

FDA Approval FDA Therapies Drugs

The AI model that is changing clinical trial design

Drug Target Review

JULY 1, 2025

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.

Clinical Trials

Clinical Trials Trials FDA Disease

Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel

BioPharma Drive: Drug Pricing

JULY 18, 2025

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.

FDA

FDA Treatment Marketing

The structure of KRASG12C bound to divarasib highlights features of potent switch-II pocket engagement

Covalent Modifiers

JULY 23, 2025

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.

FDA Approval

FDA Approval Clinical Trials FDA Trials

FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

APRIL 13, 2025

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).

Animal Testing

Animal Testing FDA Drug Development Production

FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

OCTOBER 30, 2024

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.

FDA

FDA Regulations Pharmaceuticals Production

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 rejects Ultragenyx gene therapy over manufacturing concerns

BioPharma Drive: Drug Pricing

JULY 14, 2025

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather than a roadblock.”

Therapies

Therapies FDA

FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know

thought leadership

JULY 11, 2025

A New Era of FDA Disclosure On Thursday, July 10, 2025, FDA published more than 200 decision letters, known as complete response letters (CRLs).

FDA

FDA Production Drugs Science

Comprehensive Characterization of Bruton’s Tyrosine KinaseInhibitor Specificity, Potency, and Biological Effects: Insights into Covalent and Noncovalent Mechanistic Signatures

Covalent Modifiers

MARCH 16, 2025

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.

FDA

FDA Therapies Drugs

Transforming Cancer Therapy: Insights from 2025 H1 FDA Approvals and Preclinical Drug Discovery

Crown Bioscience

JULY 17, 2025

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.

FDA Approval

FDA Approval Therapies FDA Drugs

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T Cell Immunotherapies

Drugs.com

JUNE 27, 2025

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.

FDA

FDA Drugs

Future-proofing drug development with GenAI

Drug Target Review

JULY 3, 2025

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.

Drug Development

Drug Development Drugs Animal Testing Engineering

Thienopyrimidine: Unveiling the Versatile Potential of a Promising Heterocyclic Scaffold in Drug Discovery

Chemical Biology and Drug Design

JUNE 19, 2025

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.

FDA Approval

FDA Approval Clinical Trials Virus Drugs

FDA Upgrades Recall on 160,000+ Bottles of Thyroid Medication

FDA Approves Polypill Widaplik for Hypertension

Trending Sources

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

FDA to Review and Possibly Ban Fluoride Supplements for Kids

FDA Approves First Cream for Treating Chronic Hand Eczema, Anzupgo

FDA to speed reviews for drugs supporting ‘national interests’

After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder

FDA meeting gives window into gene therapy field’s angst

FDA Approves First Twice-a-Year HIV Prevention Shot, Yeztugo

FDA Approves Prefilled Syringe Presentation for Shingles Vaccine

Lilly gets FDA OK of modified dosing for Alzheimer’s drug

FDA OKs first blood test to aid Alzheimer’s diagnosis

Analyzing Oxygen Atom Distribution in FDA‐Approved Drugs to Enhance Drug Discovery Strategies

FDA Approves First Twice-a-Year HIV Prevention Shot

FDA approves twice-yearly shot of Gilead drug for HIV prevention

New Antibody Shot, Enflonsia, Could Help Protect Babies From RSV

FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews

FDA turns back Capricor’s Duchenne cell therapy

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA, in policy shift, publishes some drug rejection letters

FDA Approves Once-Monthly Andembry for Hereditary Angioedema

Long-Lasting HIV Prevention Shot Headed Toward Approval

FDA Pathways Offer Faster Track for Oncology Drug Development

Actithera draws new investors to radiopharma drug pitch

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

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Approves Label Updates for Bristol Myers Squibb Cell Therapies, Removes REMS

FDA Launches Postmarket Chemical Review Program to Ensure Food Safety

Lilly’s Amyvid Receives FDA Label Revision to Support Alzheimer’s Diagnosis

FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis

The AI model that is changing clinical trial design

Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel

The structure of KRASG12C bound to divarasib highlights features of potent switch-II pocket engagement

FDA Eliminates Animal Testing: Impact on Biotechs

FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

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

FDA rejects Ultragenyx gene therapy over manufacturing concerns

FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know

Comprehensive Characterization of Bruton’s Tyrosine KinaseInhibitor Specificity, Potency, and Biological Effects: Insights into Covalent and Noncovalent Mechanistic Signatures

Transforming Cancer Therapy: Insights from 2025 H1 FDA Approvals and Preclinical Drug Discovery

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T Cell Immunotherapies

Future-proofing drug development with GenAI

Thienopyrimidine: Unveiling the Versatile Potential of a Promising Heterocyclic Scaffold in Drug Discovery

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