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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...

PMV Pharmaceuticals Announces Board Chair TransitionRegulatory Approvals

23 Apr 2026

PMV Pharmaceuticals Announces Board Chair Transition

PMV Pharmaceuticals announced a leadership transition on its Board of Directors, with Laurie Stelzer appointed as the new Chair, succeeding Rich Heyman, Ph.D....

Cristcot Announces FDA Acceptance of NDA for Next-Generation Hydrocortisone Acetate (ngHCA) for Treatment of Ulcerative Colitis (UC) of the RectumRegulatory Approvals

22 Apr 2026

Cristcot Announces FDA Acceptance of NDA for Next-Generation Hydrocortisone Acetate (ngHCA) for Treatment of Ulcerative Colitis (UC) of the Rectum

Cristcot announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for next-generation hydrocortisone acetate...

Opinion: As Duchenne Innovation Booms, Let’s Ensure It Becomes Real ProgressRegulatory Approvals

22 Apr 2026

Opinion: As Duchenne Innovation Booms, Let’s Ensure It Becomes Real Progress

Sarepta Therapeutics' President of Research & Development, Louise Rodino-Klapac, reflects on the evolving landscape of Duchenne muscular dystrophy (DMD)...

Replimune cuts will leave over 200 jobless in MassachusettsRegulatory Approvals

22 Apr 2026

Replimune cuts will leave over 200 jobless in Massachusetts

Replimune announced significant layoffs affecting 224 employees across its Woburn headquarters and Framingham manufacturing site in Massachusetts. This...

Trump throws support behind psychedelics with executive orderRegulatory Approvals

22 Apr 2026

Trump throws support behind psychedelics with executive order

President Donald Trump signed an executive order on April 20, 2026, to accelerate the development and facilitate broader access to psychedelic therapies for...

Orion Pharma’s ODM-212 Granted Orphan Drug Designation in Mesothelioma by the US FDARegulatory Approvals

22 Apr 2026

Orion Pharma’s ODM-212 Granted Orphan Drug Designation in Mesothelioma by the US FDA

Orion Corporation announced that its investigational drug ODM-212 received Orphan Drug Designation (ODD) from the US FDA for the treatment of mesothelioma, a...

Trump instructs FDA to accelerate psychedelics developmentRegulatory Approvals

22 Apr 2026

Trump instructs FDA to accelerate psychedelics development

President Donald Trump issued an executive order on April 18, 2026, directing the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to psychedelic...

Akeso's Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast CancerRegulatory Approvals

03 Nov 2025

Akeso's Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast Cancer

Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Adm...

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31 Oct 2025

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Vizient Applauds FDA Actions to Accelerate Biosimilar Development and Lower CostsRegulatory Approvals

31 Oct 2025

Vizient Applauds FDA Actions to Accelerate Biosimilar Development and Lower Costs

Vizient commends the FDA for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater cla...

FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) for Pulmonary Arterial Hypertension Based on Phase 3 ZENITH StudyRegulatory Approvals

27 Oct 2025

FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) for Pulmonary Arterial Hypertension Based on Phase 3 ZENITH Study

Merck announced that the FDA has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) based on the Phase 3 ZENITH trial. The...

FDA Approves Genentech's Gazyva for Lupus Nephritis TreatmentRegulatory Approvals

20 Oct 2025

FDA Approves Genentech's Gazyva for Lupus Nephritis Treatment

The FDA has approved Genentech's Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis (LN) receiving standard therapy. The ap...

OS Therapies Receives FDA and MHRA Feedback on OST-HER2 for Metastatic OsteosarcomaRegulatory Approvals

17 Oct 2025

OS Therapies Receives FDA and MHRA Feedback on OST-HER2 for Metastatic Osteosarcoma

OS Therapies Inc. announced that the FDA granted a Type C meeting to discuss clinical efficacy data endpoints for a BLA under the Accelerated Approval...

Civica to Launch Affordable Long-Acting Insulin Glargine in the USRegulatory Approvals

16 Oct 2025

Civica to Launch Affordable Long-Acting Insulin Glargine in the US

Non-profit pharmaceutical company Civica is set to launch a long-acting insulin, insulin glargine-yfgn, in pre-filled pens at the lowest list price in...

Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCCRegulatory Approvals

14 Oct 2025

Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCC

Bicara Therapeutics announced that the FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for...

MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes PatientsRegulatory Approvals

14 Oct 2025

MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes Patients

MannKind Corporation announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Afrezza (insulin human) Inhalation ...

Palisade Bio Receives Canadian Patent for PALI-2108 CompositionRegulatory Approvals

14 Oct 2025

Palisade Bio Receives Canadian Patent for PALI-2108 Composition

Palisade Bio announced that the Canadian Intellectual Property Office has granted patent number 3,174,137 for the composition of PALI-2108, its orally...

FDA Approves Boehringer Ingelheim's Jascayd (Nerandomilast) for Idiopathic Pulmonary FibrosisRegulatory Approvals

09 Oct 2025

FDA Approves Boehringer Ingelheim's Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

The U.S. FDA has approved Boehringer Ingelheim's JASCAYD® (nerandomilast) tablets as the first new treatment option in over a decade for adults with I...

Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Tralesinidase Alfa for Sanfilippo Syndrome Type BRegulatory Approvals

07 Oct 2025

Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Tralesinidase Alfa for Sanfilippo Syndrome Type B

Spruce Biosciences received Breakthrough Therapy Designation from the FDA for tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment...

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for Cognitive Impairment Associated with SchizophreniaRegulatory Approvals

06 Oct 2025

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for Cognitive Impairment Associated with Schizophrenia

Alto Neuroscience received FDA Fast Track designation for ALTO-101 for treating cognitive impairment associated with schizophrenia (CIAS). ALTO-101, a...

Cellectar Biosciences Announces EMA Eligibility for Conditional Marketing Authorization of Iopofosine I 131 for Refractory Waldenstrom MacroglobulinemiaRegulatory Approvals

06 Oct 2025

Cellectar Biosciences Announces EMA Eligibility for Conditional Marketing Authorization of Iopofosine I 131 for Refractory Waldenstrom Macroglobulinemia

Cellectar Biosciences announced that the European Medicines Agency (EMA) has confirmed the eligibility to file for Conditional Marketing Authorization...

AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450Regulatory Approvals

02 Oct 2025

AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450

AEON Biopharma announced that the FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 (prabotulinumtoxinA)...

Vanda Pharmaceuticals Announces Collaborative Framework with FDA for Dispute ResolutionRegulatory Approvals

02 Oct 2025

Vanda Pharmaceuticals Announces Collaborative Framework with FDA for Dispute Resolution

Vanda Pharmaceuticals and the FDA have agreed on a collaborative framework to resolve disputes regarding HETLIOZ® (tasimelteon) and tradipitant. The F...

Kedrion Biopharma Receives FDA Approval for QIVIGY for Primary Humoral ImmunodeficiencyRegulatory Approvals

30 Sept 2025

Kedrion Biopharma Receives FDA Approval for QIVIGY for Primary Humoral Immunodeficiency

Kedrion Biopharma announced FDA approval for QIVIGY (Immune Globulin 10% IV) for treating adults with primary humoral immunodeficiency (PI). QIVIGY, a...

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