FDA Accepts New Drug Application for Vatiquinone to Treat Friedreich Ataxia
Drug Topics
FEBRUARY 19, 2025
The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.
FDA Approves Generic Liraglutide for Type 2 Diabetes
Drug Topics
APRIL 3, 2025
As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023.
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COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations
Drug Topics
AUGUST 22, 2024
Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.
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FDA Approves Denosumab-Bnht as Biosimilar to Prolia, Xgeva
Drug Topics
MARCH 27, 2025
Denosumab-bnht (Conexxence, Bomyntra) became the third biosimilar in 2025 to be approved for denosumab (Prolia, Xgeva).
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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs
The FDA Law Blog
APRIL 8, 2025
Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.
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FDA issues first recommendations on AI for drug development
European Pharmaceutical Review
JANUARY 7, 2025
The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drug development.
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FDA Approves GSK's BLA for 5-in-1 Meningococcal Vaccine
Drug Topics
APRIL 16, 2024
The company’s investigational ABCWY vaccine candidate will be reviewed by the FDA by February 14, 2025.
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FDA Recommends 2025-2026 COVID-19 Vaccines Be Monovalent, Target LP.8.1 Strain
Pharmacy Times
MAY 27, 2025
Following a meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA announced their recommendation of COVID-19 vaccines targeting LP.8.1, a strain of the JN.1 1 variant that has become dominant in the US.
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FDA Approves Apomorphine for Treatment of Motor Fluctuations in Parkinson Disease
Drug Topics
FEBRUARY 4, 2025
The drug will be made available in the second quarter of 2025.
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FDA Accepts NDA for Delgocitinib Cream to Treat Chronic Hand Eczema
Drug Topics
SEPTEMBER 23, 2024
LEO Pharma expects the regulatory review process to be completed in the second half of 2025.
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FDA Grants Priority Review to Brensocatib for Non-Cystic Fibrosis Bronchiectasis
Drug Topics
FEBRUARY 6, 2025
With the acceptance of the new drug application and granting priority review, the target action date is August 12, 2025.
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FDA approves generic Xarelto
The Checkup by Singlecare
MARCH 7, 2025
On March 4, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of the first generic form of Xarelto (rivaroxaban), a popular anticoagulant medication. To gain FDA approval , a generic medication must be proven to work the same and provide the same benefits as the brand-name medication.
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FDA Accepts BLA Resubmission for Epidermolysis Bullosa Gene Therapy
Drug Topics
NOVEMBER 12, 2024
The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.
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Marketing in Pharma: Strategies that work in 2025
Pharma Marketing Network
APRIL 2, 2025
In 2025, the strategies that succeed are rooted in personalization, innovation, and real-time adaptability. In 2025, the ability to react to these preferences in near real time is what separates leading pharma marketing teams from the rest. FAQs What is the biggest trend in marketing in pharma in 2025?
Third Ustekinumab Biosimilar Gains FDA Approval
Drug Topics
JULY 10, 2024
Ustekinumab-ttwe, a biosimilar to ustekinumab (Stelara) is expected launch in the US in February 2025.
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FDA Clears Tandem’s Automated Insulin Delivery Algorithm For T2D
Drug Topics
FEBRUARY 25, 2025
The technology will be available to patients in the United States in March 2025.
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216 FDA Approves First Treatment for Hypoparathyroidism in Adults
Drug Topics
AUGUST 12, 2024
Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.
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FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms
Drug Topics
OCTOBER 10, 2024
The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.
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FDA Grants Tentative Approval to Treprostinil for PAH Associated With PH-ILD
Drug Topics
AUGUST 20, 2024
Final approval of the therapy may occur after expiration of the 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.
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FDA decision on oral Wegovy coming in Q4
pharmaphorum
MAY 5, 2025
FDA decision on oral Wegovy coming in Q4 Jonah.Comstock Mon, 05/05/2025 - 15:15 Bookmark this
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Pharmacy Law and Licensing Highlights 2025
The FDA Law Blog
FEBRUARY 2, 2025
By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.
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59 4 closely-watched FDA approval dates in 2025 from Vertex, Novo, J&J and more
PharmaVoice
JANUARY 6, 2025
A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.
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AI-Powered Pharma Marketing: What 2025 Has in Store
Pharma Marketing Network
APRIL 24, 2025
In 2025, AI-powered pharma marketing is transforming how companies engage healthcare professionals (HCPs), patients, and stakeholders. Is AI in pharma marketing FDA-regulated? While AI itself isnt regulated, any content or interaction that includes product claims must follow FDA promotional guidelines.
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Why 2025 Will Be a Breakout Year for Pharma Marketing Innovation
Pharma Marketing Network
APRIL 28, 2025
Pharma marketing innovation is poised for an unprecedented surge in 2025, driven by new technologies, regulatory shifts, and evolving patient expectations. This article dives deep into why 2025 will mark a pivotal moment for pharma marketing and how savvy brands can stay ahead.
FDA chief Martin Makary sets June deadline for genAI rollout
Pharmaceutical Technology
MAY 9, 2025
The US Food and Drug Administration (FDA) has set an "aggressive" timeline to implement genAI across the agency by 30 June 2025.
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10 Innovative Trends in Pharma Marketing: Strategies for Industry Success in 2025
Pharma Marketing Network
DECEMBER 4, 2024
As we approach 2025, emerging trends are reshaping how the industry engages with patients and healthcare providers. Adhering to guidelines from the FDA and other governing bodies ensures that campaigns remain effective without crossing ethical boundaries. Navigating these requires a fine balance between creativity and compliance.
FDA Accepts sNDA of Roflumilast Foam for Scalp and Body Psoriasis
Pharmacy Times
SEPTEMBER 24, 2024
The FDA assigned a Prescription Drug User Fee Act action date of May 22, 2025.
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FDA Accepts Biologics License Application For Nivolumab Plus Ipilimumab to Treat Hepatocellular Carcinoma
Pharmacy Times
AUGUST 22, 2024
The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.
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New FDA head says no more pharma on advisory committees
pharmaphorum
APRIL 18, 2025
New FDA head says no more pharma on advisory committees Jonah.Comstock Fri, 18/04/2025 - 17:43 Bookmark this
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FDA advisory panel recommends a streamlined flu vaccine for next fall
STAT
MARCH 5, 2024
Experts who advise the Food and Drug Administration on vaccine-related issues voted unanimously on Tuesday to recommend that the FDA approve trivalent flu vaccines for the 2024-2025 season, instead of the quadrivalent, or four-in-one, shots that have been the industry standard for the past decade or so. Read the rest…
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STAT+: Drugs are still mostly tested in white men. Will the FDA change that next year?
STAT
DECEMBER 21, 2023
But planning isn’t the same as doing, the industry’s track record isn’t great, and it’s not clear whether the FDA will twist arms, experts told STAT. Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials.
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Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025
The FDA Law Blog
APRIL 13, 2025
By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). FDA did not object to the timing of the respective submissions in either letter.
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Google gives ex-FDA digital health head Bakul Patel strategic role
pharmaphorum
MAY 18, 2022
FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Current FDA Commissioner Robert Califf spent some time as an advisor to Google parent Alphabet after his earlier stint at the head of the regulator. Bakul Patel.
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Sanofi's Dupixent gets FDA nod for chronic hives indication
pharmaphorum
APRIL 21, 2025
Sanofi's Dupixent gets FDA nod for chronic hives indication Jonah.Comstock Mon, 21/04/2025 - 13:45 Bookmark this
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New J&J data signals progress in ulcerative colitis treatment landscape
European Pharmaceutical Review
MAY 5, 2025
The new findings are being shown at Digestive Disease Week (DDW) 2025 (presentation #4241842). The US Food and Drug Administration (FDA) most recently approved Tremfya in March 2025 for adult patients with Crohns disease, for subcutaneous and intravenous induction administration options.
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FDA Accepts Resubmitted NDA for AXS-07 for Acute Treatment of Migraine
Pharmacy Times
SEPTEMBER 10, 2024
The FDA assigned a Prescription Drug User Fee Action date is January 31, 2025.
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FDA Accepts NDA and Priority Review Application for Vimseltinib in Tenosynovial Giant Cell Tumors
Pharmacy Times
AUGUST 20, 2024
Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.
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Amgen grabs FDA thumbs up for Soliris biosim, eyes 2025 launch
Fierce Pharma
MAY 29, 2024
-first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. first Humira biosim launch last year and its planned Stelara biosim rollout in 2025. But thanks to a new FDA approval, the company is nearing yet another biosimilar launch.
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STAT+: Pharmalittle: We’re reading about FDA chaos delaying a rare disease drug, Merck’s U.S. investment, and more
STAT
APRIL 29, 2025
supply for 2025 and is working on expanding manufacturing for the future. An FDA spokesperson declined to comment on the reasons for the delay in meeting the official date, citing confidentiality, and referred us to the company. Keytruda accounts for roughly half of the company’s revenue, and last year generated $29.5
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No ACNU Yet; Effective Date Delayed Again
The FDA Law Blog
MARCH 23, 2025
Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.
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ACI’s 43rd FDA Boot Camp – New York City Edition
The FDA Law Blog
FEBRUARY 27, 2025
The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.
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FDA oncology advisory committee to weigh Exelixis' Cabometyx in neuroendocrine tumors
Fierce Pharma
NOVEMBER 27, 2024
Before Exelexis’ Cabometyx can pass muster with the FDA in its hopeful neuroendocrine tumors indication next April, it will have to first face the agency’s Oncologic Drugs Advisory Committee ( | The agency's Oncologic Drugs Advisory Committee is set to discuss the treatment and its phase 3 CABINET study in March ahead of the FDA's planned (..)
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Enforcement Under the New FDA: HPM to Host a Q&A Webinar on FDC Act Enforcement with Three Former Federal Prosecutors
The FDA Law Blog
APRIL 16, 2025
is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. The panelists will also share their predictions on the increased role of state agencies and other prosecutions in the FDA space. Claud Hyman, Phelps & McNamara, P.C.
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FDA approves Wezlana for inflammatory conditions
The Checkup by Singlecare
NOVEMBER 6, 2023
Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response. How much will Wezlana cost?
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