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Curanex Reports First Quarter 2026 Business Progress as Phyto-N Advances Toward Planned FDA SubmissionRegulatory Approvals

15 May 2026

Curanex Reports First Quarter 2026 Business Progress as Phyto-N Advances Toward Planned FDA Submission

Curanex Pharmaceuticals provided a first quarter 2026 business update, highlighting continued progress with its lead drug candidate, Phyto-N. The company is...

FDA Approves New Dosing Option for CRYSVITA® (burosumab-twza) in Adults With XLHRegulatory Approvals

15 May 2026

FDA Approves New Dosing Option for CRYSVITA® (burosumab-twza) in Adults With XLH

Kyowa Kirin announced on May 14, 2026, that the U.S. Food and Drug Administration (FDA) has approved a dosing update for CRYSVITA® (burosumab-twza) in adults...

Arbutus Reports First Quarter 2026 Financial Results and Provides Corporate UpdateRegulatory Approvals

14 May 2026

Arbutus Reports First Quarter 2026 Financial Results and Provides Corporate Update

Arbutus Biopharma reported strong first-quarter 2026 financial results, significantly boosted by a major litigation settlement. The company, along with its...

Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business UpdateRegulatory Approvals

14 May 2026

Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

Aquestive Therapeutics reported its first quarter 2026 financial results, demonstrating increased revenue and a significantly reduced net loss. The company...

FDA Advances Drug Repurposing to Address Unmet Medical NeedsRegulatory Approvals

12 May 2026

FDA Advances Drug Repurposing to Address Unmet Medical Needs

On May 11, 2026, the U.S. Food and Drug Administration announced it is soliciting public input on efforts to advance drug repurposing to address unmet medical...

aTyr Pharma Provides Regulatory and Clinical Update for Efzofitimod in Pulmonary Sarcoidosis Following FDA Type C MeetingRegulatory Approvals

12 May 2026

aTyr Pharma Provides Regulatory and Clinical Update for Efzofitimod in Pulmonary Sarcoidosis Following FDA Type C Meeting

aTyr Pharma announced its path forward for efzofitimod in pulmonary sarcoidosis after receiving official minutes from a Type C meeting with the U.S. Food and...

Sanofi requests removal of Tzield from CNPV program after Høeg gets involvedRegulatory Approvals

11 May 2026

Sanofi requests removal of Tzield from CNPV program after Høeg gets involved

Sanofi has reportedly requested the FDA remove its type 1 diabetes drug, teplizumab (Tzield), from the Commissioner’s National Priority Review (CNPV) program....

FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exitRegulatory Approvals

11 May 2026

FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit

The FDA has reversed its previous rejections of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals' cell therapy, Ebvallo, for Epstein-Barr virus-positive...

Lexicon Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Clinical UpdatesRegulatory Approvals

11 May 2026

Lexicon Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Clinical Updates

Lexicon Pharmaceuticals reported its first-quarter 2026 financial results and provided key clinical updates across its cardiometabolic pipeline. The company...

Foundayo’s liver failure blip weighs down Lilly shares but analysts unconcernedRegulatory Approvals

07 May 2026

Foundayo’s liver failure blip weighs down Lilly shares but analysts unconcerned

A single case of hepatic failure associated with Eli Lilly’s weight-loss pill Foundayo was reported in the FDA’s Adverse Event Reporting System (FAERS),...

Passage cuts 75% of workforce after FDA trial design requestRegulatory Approvals

05 May 2026

Passage cuts 75% of workforce after FDA trial design request

Passage Bio is cutting approximately 75% of its workforce, impacting around 18 employees, to reduce operating expenses. This decision follows the FDA's...

FDA Reviewing Argenx's Vyvgart Label Expansion for Seronegative Myasthenia GravisRegulatory Approvals

05 May 2026

FDA Reviewing Argenx's Vyvgart Label Expansion for Seronegative Myasthenia Gravis

Argenx is seeking to expand the label of its generalized myasthenia gravis (gMG) drug, Vyvgart, to include patients who are seronegative for acetylcholine...

FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed dataRegulatory Approvals

05 May 2026

FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data

The FDA has approved Veppanu (vepdegestrant), developed by Pfizer and Arvinas, as the first-ever PROTAC therapy for advanced or metastatic ER-positive,...

FDA ODAC Panel Votes Against AstraZeneca's Camizestrant for HER2-Negative Breast CancerRegulatory Approvals

05 May 2026

FDA ODAC Panel Votes Against AstraZeneca's Camizestrant for HER2-Negative Breast Cancer

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6-3 against the approval of AstraZeneca's oral SERD camizestrant for HER2-negative advanced breast...

UniQure to Seek UK Approval for Huntington’s Gene TherapyRegulatory Approvals

01 May 2026

UniQure to Seek UK Approval for Huntington’s Gene Therapy

UniQure announced plans to submit a marketing application for its gene therapy, AMT-130, in the U.K. later this year, following a positive meeting with U.K....

Nicox Provides Full Year 2025 Financial Results and Corporate UpdateRegulatory Approvals

01 May 2026

Nicox Provides Full Year 2025 Financial Results and Corporate Update

Nicox SA reported its full-year 2025 financial results, demonstrating a significant improvement with revenue reaching €16.8 million, up from €7.9 million in...

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks ListRegulatory Approvals

01 May 2026

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List

The U.S. Food and Drug Administration (FDA) has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, asserting there is no...

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with DementiaRegulatory Approvals

01 May 2026

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

The U.S. Food and Drug Administration (FDA) has approved Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets for the...

Sanofi and Novartis Kick Off Q1 Earnings SeasonRegulatory Approvals

30 Apr 2026

Sanofi and Novartis Kick Off Q1 Earnings Season

Sanofi and Novartis have initiated the first-quarter earnings season, with both companies actively defending patents for their respective key drugs. Sanofi is...

Amgen, AstraZeneca join FDA effort harnessing cloud for real-time clinical trialsRegulatory Approvals

30 Apr 2026

Amgen, AstraZeneca join FDA effort harnessing cloud for real-time clinical trials

The FDA has launched a new initiative for real-time clinical trials, enabling drug sponsors to transmit data immediately to the regulator via cloud technology....

AstraZeneca faces uphill battle at upcoming adcomm in face of FDA questionsRegulatory Approvals

30 Apr 2026

AstraZeneca faces uphill battle at upcoming adcomm in face of FDA questions

The FDA has released briefing documents raising significant doubts about two AstraZeneca cancer drugs, camizestrant and Truqap, ahead of an advisory committee...

FDA alleges ‘manipulated’ data supported approval of Amgen’s autoimmune drugRegulatory Approvals

29 Apr 2026

FDA alleges ‘manipulated’ data supported approval of Amgen’s autoimmune drug

The FDA has renewed its call for Amgen to withdraw its autoimmune drug Tavneos from the market, alleging that study personnel manipulated data in the pivotal...

Intellia heads to FDA after notching first late-stage win for in vivo gene editorRegulatory Approvals

28 Apr 2026

Intellia heads to FDA after notching first late-stage win for in vivo gene editor

Intellia Therapeutics announced positive topline results from its Phase 3 HAELO study of lonvo-z, an in vivo CRISPR-based gene editing therapy for hereditary...

UCSF, Par Health hit with FDA warning letters for environmental monitoring issuesRegulatory Approvals

28 Apr 2026

UCSF, Par Health hit with FDA warning letters for environmental monitoring issues

The FDA issued warning letters to UCSF Radiopharmaceutical Facility and Par Health, citing significant deficiencies in their environmental monitoring and...

Gene therapy leaders aim to help more Baby KJs with novel regulatory modelsRegulatory Approvals

28 Apr 2026

Gene therapy leaders aim to help more Baby KJs with novel regulatory models

Cell and gene therapy leaders are discussing ways to accelerate bespoke gene editing treatments for children, exemplified by Baby KJ Muldoon's successful...

MediPharm Labs Positioned to Serve Growing U.S. Pharmaceutical and Clinical Research Demand Following Cannabis ReschedulingRegulatory Approvals

28 Apr 2026

MediPharm Labs Positioned to Serve Growing U.S. Pharmaceutical and Clinical Research Demand Following Cannabis Rescheduling

MediPharm Labs Corp. welcomes the U.S. Department of Justice and DEA's final order rescheduling FDA-approved cannabis drug products and state-licensed medical...

Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapsesRegulatory Approvals

27 Apr 2026

Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for Sanofi’s Cenrifki...

FDA Awards Priority Vouchers for Investigational PsychedelicsRegulatory Approvals

27 Apr 2026

FDA Awards Priority Vouchers for Investigational Psychedelics

The FDA has awarded Commissioner’s National Priority Vouchers (CNPVs) to three undisclosed companies developing psychedelic therapies, following an executive...

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)Regulatory Approvals

27 Apr 2026

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion...

Regeneron finally joins Trump’s drug pricing push while notching landmark approvalRegulatory Approvals

27 Apr 2026

Regeneron finally joins Trump’s drug pricing push while notching landmark approval

Regeneron has agreed to the Trump administration's Most Favored Nation drug pricing initiative, becoming the last of 17 companies to comply after nearly nine...

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive OrderRegulatory Approvals

27 Apr 2026

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

The U.S. Food and Drug Administration (FDA) announced a series of regulatory actions to accelerate access to treatments for serious mental illness, including...

Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infantsRegulatory Approvals

27 Apr 2026

Novartis malaria treatment Coartem® Baby receives WHO prequalification, paving way for greater access for newborns and young infants

Novartis announced that its malaria treatment, Coartem® (artemether-lumefantrine) Baby, has received World Health Organization (WHO) prequalification. This...

Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trustRegulatory Approvals

27 Apr 2026

Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust

The FDA's Center for Biologics Evaluation and Research (CBER) faces a significant trust problem with industry sponsors, patients, and advocates in the rare...

FDA Approval of Regeneron’s Hearing Loss Gene Therapy Breaks BarriersRegulatory Approvals

24 Apr 2026

FDA Approval of Regeneron’s Hearing Loss Gene Therapy Breaks Barriers

Regeneron Pharmaceuticals has received FDA approval for Otarmeni, its gene therapy for congenital deafness caused by otoferlin protein deficiency. This marks...

Tilray Brands Applauds Cannabis Rescheduling to Schedule IIIRegulatory Approvals

24 Apr 2026

Tilray Brands Applauds Cannabis Rescheduling to Schedule III

Tilray Brands, Inc. issued a statement applauding President Donald Trump’s actions leading to the rescheduling of cannabis from Schedule I to Schedule III...

Sanofi and Regeneron’s Dupixent Approved in the US as the First Biologic Medicine for Young Children with Uncontrolled Chronic Spontaneous UrticariaRegulatory Approvals

23 Apr 2026

Sanofi and Regeneron’s Dupixent Approved in the US as the First Biologic Medicine for Young Children with Uncontrolled Chronic Spontaneous Urticaria

The US FDA has approved Dupixent (dupilumab), co-developed by Sanofi and Regeneron, as the first biologic medicine for children aged two to 11 years with...

Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approvalRegulatory Approvals

23 Apr 2026

Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approval

Merck's daily pill Idvynso (doravirine and islatravir) received FDA approval on April 22, 2026, for the treatment of virologically suppressed HIV-1 in adults....

Amid US ordeal, Moderna wins EU approval for flu/COVID-19 combo shotRegulatory Approvals

23 Apr 2026

Amid US ordeal, Moderna wins EU approval for flu/COVID-19 combo shot

Moderna has secured the European Commission’s go-ahead for its combination flu and COVID-19 vaccine, mCOMBRIAX, for active immunization of people 50 years and...

Ionis’ antisense drug stabilizes ultra-rare disease ahead of FDA decisionRegulatory Approvals

23 Apr 2026

Ionis’ antisense drug stabilizes ultra-rare disease ahead of FDA decision

Ionis Pharmaceuticals announced new data for its investigational antisense oligonucleotide, zilganersen, for Alexander disease (AxD), an ultra-rare...

FDA issues warning letter after GLP-1 manufacturer refuses inspectors accessRegulatory Approvals

23 Apr 2026

FDA issues warning letter after GLP-1 manufacturer refuses inspectors access

The FDA has issued a warning letter to New Life Pharma after the company refused inspectors access to sections of its New Jersey GLP-1 manufacturing facility...

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