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Kamada Announces FDA Approval of its New In-House Rabies Virus Neutralization Testing LaboratoryRegulatory Approvals

02 Jun 2026

Kamada Announces FDA Approval of its New In-House Rabies Virus Neutralization Testing Laboratory

Kamada Ltd. announced FDA approval for its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory, located in Beit Kama, Israel. This...

Cognition Therapeutics Participating in Upcoming Investor ConferencesRegulatory Approvals

02 Jun 2026

Cognition Therapeutics Participating in Upcoming Investor Conferences

Cognition Therapeutics, Inc. announced that its President and CEO, Lisa Ricciardi, will present at two upcoming financial conferences in June 2026. She will...

Allogene CEO David Chang to Step DownRegulatory Approvals

29 May 2026

Allogene CEO David Chang to Step Down

Allogene Therapeutics announced CEO David Chang will step down after an eight-year tenure, effective July 1. Zachary Roberts, current research chief and Chief...

Replimune gives cancer immunotherapy a third try after FDA leadership shakeupRegulatory Approvals

29 May 2026

Replimune gives cancer immunotherapy a third try after FDA leadership shakeup

Replimune is resubmitting its biologics license application (BLA) for its melanoma therapy, RP1, in combination with Bristol Myers Squibb’s PD-1 blocker...

Optimi Health Welcomes Expanded Psychedelic-Assisted Therapy Access Under Updated Authorized Prescriber Framework in AustraliaRegulatory Approvals

29 May 2026

Optimi Health Welcomes Expanded Psychedelic-Assisted Therapy Access Under Updated Authorized Prescriber Framework in Australia

Optimi Health Corp. announced its acknowledgment of the final recommendations published by the Therapeutic Goods Administration (TGA) in Australia. These...

FDA delays verdict on Beren’s rare disease drug by three monthsRegulatory Approvals

29 May 2026

FDA delays verdict on Beren’s rare disease drug by three months

The FDA has extended its decision date for Beren Therapeutics’ intrathecal injection, adrabetadex, for infantile-onset Niemann-Pick disease type C. Initially...

ETF recommends updating COVID-19 vaccines to target XFG variantRegulatory Approvals

29 May 2026

ETF recommends updating COVID-19 vaccines to target XFG variant

The European Medicines Agency's (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the SARS-CoV-2 XFG variant for the...

Hansa Biopharma’s Idefirix Achieves 90% One-Year Graft Failure-Free Survival in Kidney Transplant StudyRegulatory Approvals

29 May 2026

Hansa Biopharma’s Idefirix Achieves 90% One-Year Graft Failure-Free Survival in Kidney Transplant Study

Hansa Biopharma announced positive results from its open-label, European 20-HMedIdeS-19 post-authorisation efficacy study (PAES) (NCT05369975) for Idefirix...

FDA accelerated approval of Hepcludex significant milestone for US HDV marketRegulatory Approvals

29 May 2026

FDA accelerated approval of Hepcludex significant milestone for US HDV market

Gilead Sciences has received accelerated approval from the US FDA for Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus (HDV) without...

Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher diseaseRegulatory Approvals

29 May 2026

Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease

Sanofi's venglustat, an investigational oral glucosylceramide synthase inhibitor, has been granted priority review by the US FDA for the treatment of type 3...

AbbVie snags FDA’s first ADC approval for ultra-rare blood cancerRegulatory Approvals

29 May 2026

AbbVie snags FDA’s first ADC approval for ultra-rare blood cancer

AbbVie has received FDA approval for Decnupaz, its first antibody-drug conjugate (ADC), for the treatment of blastic plasmacytoid dendritic cell neoplasm...

AstraZeneca’s Breast Cancer Pill Hit with Review Delay After Negative Adcomm VoteRegulatory Approvals

28 May 2026

AstraZeneca’s Breast Cancer Pill Hit with Review Delay After Negative Adcomm Vote

AstraZeneca's oral SERD drug, camizestrant, for advanced breast cancer, has faced a review delay from the FDA following a negative advisory committee vote. The...

FDA Assembles Vaccine Experts to Update COVID-19 FormulationRegulatory Approvals

28 May 2026

FDA Assembles Vaccine Experts to Update COVID-19 Formulation

The FDA is convening its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on May 28, 2026, to discuss updating COVID-19 vaccine...

FDA accepts BridgeBio’s application for potential first limb-girdle muscular dystrophy drugRegulatory Approvals

28 May 2026

FDA accepts BridgeBio’s application for potential first limb-girdle muscular dystrophy drug

The FDA has granted priority review to BridgeBio’s BBP-418 for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), setting a target action date of November...

Ionetix Announces Approval of Abbreviated New Drug Application for Gallium Ga-68 Gozetotide (PSMA-11)Regulatory Approvals

27 May 2026

Ionetix Announces Approval of Abbreviated New Drug Application for Gallium Ga-68 Gozetotide (PSMA-11)

Ionetix Corporation announced that the Federal Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Gallium Ga-68 gozetotide....

REGENXBIO Reports Mixed Pivotal Data for DMD Gene Therapy RGX-202Regulatory Approvals

27 May 2026

REGENXBIO Reports Mixed Pivotal Data for DMD Gene Therapy RGX-202

REGENXBIO announced mixed pivotal data for its investigational gene therapy, RGX-202, for Duchenne muscular dystrophy. The Phase 3 portion of the trial...

Astellas eyes more cost cuts; FDA panel to debate Moderna vaccineRegulatory Approvals

27 May 2026

Astellas eyes more cost cuts; FDA panel to debate Moderna vaccine

Astellas Pharma has announced a new strategic plan aimed at achieving sustainable growth and mitigating the impact of patent expiry for its prostate cancer...

Novo Nordisk A/S: CHMP recommends EU approval of Wegovy® 7.2 mg in a single-dose pen, providing up to 20.7% mean weight lossRegulatory Approvals

22 May 2026

Novo Nordisk A/S: CHMP recommends EU approval of Wegovy® 7.2 mg in a single-dose pen, providing up to 20.7% mean weight loss

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion...

FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) InfectionRegulatory Approvals

22 May 2026

FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection

The U.S. Food and Drug Administration (FDA) has approved Hepcludex (bulevirtide-gmod) injection, developed by Gilead Sciences, Inc., as the first treatment for...

The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable (TEV-‘749) for the Treatment of Schizophrenia in AdultsRegulatory Approvals

22 May 2026

The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable (TEV-‘749) for the Treatment of Schizophrenia in Adults

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., and Medincell announced that the European Medicines Agency (EMA)...

Cognition Therapeutics Completes Meeting with FDA for Zervimesine (CT1812) in Dementia with Lewy Bodies with PsychosisRegulatory Approvals

22 May 2026

Cognition Therapeutics Completes Meeting with FDA for Zervimesine (CT1812) in Dementia with Lewy Bodies with Psychosis

Cognition Therapeutics, Inc. held a productive meeting with the U.S. Food and Drug Administration (FDA) on May 20, 2026. The discussion focused on reviewing...

CHMP issues positive opinion for JASCAYD® (nerandomilast), bringing a new IPF and PPF therapy closer to patients in the EURegulatory Approvals

22 May 2026

CHMP issues positive opinion for JASCAYD® (nerandomilast), bringing a new IPF and PPF therapy closer to patients in the EU

Boehringer Ingelheim's JASCAYD® (nerandomilast) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European...

Reversal After 20 Deaths Allows New Japan Patients to Take Amgen’s Rare Disease Drug TavneosRegulatory Approvals

22 May 2026

Reversal After 20 Deaths Allows New Japan Patients to Take Amgen’s Rare Disease Drug Tavneos

Kissei Pharmaceutical has reversed its recommendation against prescribing Amgen-shared Tavneos to new patients in Japan, following new warnings from Japan’s...

Moderna’s once-rebuffed mRNA flu shot to face scrutiny from FDA adcommRegulatory Approvals

22 May 2026

Moderna’s once-rebuffed mRNA flu shot to face scrutiny from FDA adcomm

The FDA will convene its Vaccines and Related Biological Products Advisory Committee on June 18, 2026, to assess Moderna’s investigational mRNA flu vaccine,...

Otarmeni™ (lunsotogene parvec) Receives EMA Filing Acceptance for Genetic Hearing LossRegulatory Approvals

22 May 2026

Otarmeni™ (lunsotogene parvec) Receives EMA Filing Acceptance for Genetic Hearing Loss

Regeneron Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted for review under Accelerated Assessment the Marketing Authorization...

China approves HERNEXEOS® as first targeted oral treatment option for HER2-mutant advanced NSCLC at initial diagnosisRegulatory Approvals

22 May 2026

China approves HERNEXEOS® as first targeted oral treatment option for HER2-mutant advanced NSCLC at initial diagnosis

Boehringer Ingelheim's HERNEXEOS (zongertinib tablets) has received conditional approval from China's National Medical Products Administration (NMPA) as an...

Revolution Medicines' RAS Inhibitor Shows Promise in Pancreatic CancerRegulatory Approvals

21 May 2026

Revolution Medicines' RAS Inhibitor Shows Promise in Pancreatic Cancer

Revolution Medicines' RAS inhibitor demonstrated significant efficacy by doubling survival in a Phase 3 clinical trial for pancreatic cancer. This positive...

FDA sends warning letter after Chinese supplier breaks GLP-1 import restrictionsRegulatory Approvals

21 May 2026

FDA sends warning letter after Chinese supplier breaks GLP-1 import restrictions

The FDA issued a warning letter to Chinese manufacturer Harbin Jixianglong Biotech for allegedly circumventing import restrictions on GLP-1 receptor agonist...

Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provides Business UpdateRegulatory Approvals

21 May 2026

Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provides Business Update

Roivant Sciences reported its financial results for the fourth quarter and fiscal year ended March 31, 2026, alongside a comprehensive business update. Key...

BioSyent Announces Health Canada Approval of Thyconvi™ (levothyroxine oral solution)Regulatory Approvals

21 May 2026

BioSyent Announces Health Canada Approval of Thyconvi™ (levothyroxine oral solution)

BioSyent Inc. announced that Health Canada has approved Thyconvi™ (levothyroxine sodium), establishing it as the first and only levothyroxine oral solution...

FDA’s own report shows no child deaths definitively caused by COVID vaccinationRegulatory Approvals

21 May 2026

FDA’s own report shows no child deaths definitively caused by COVID vaccination

The FDA's long-awaited analysis of adverse events related to COVID-19 vaccines in children found no definitive link between the vaccines and pediatric deaths....

Amgen’s rare disease drug Tavneos tied to 20 deaths in JapanRegulatory Approvals

21 May 2026

Amgen’s rare disease drug Tavneos tied to 20 deaths in Japan

Amgen's autoimmune drug Tavneos has been linked to 20 deaths in Japan since its 2022 launch, primarily due to vanishing bile duct syndrome (VBS), a...

AstraZeneca wins nod for blood pressure pill, opening new class of hypertension drugsRegulatory Approvals

21 May 2026

AstraZeneca wins nod for blood pressure pill, opening new class of hypertension drugs

AstraZeneca has received FDA approval for Baxfendy (baxdrostat), an aldosterone synthase inhibitor, for the treatment of uncontrolled or treatment-resistant...

Future of Aardvark’s Prader-Willi drug in doubt as FDA slaps full hold on programRegulatory Approvals

18 May 2026

Future of Aardvark’s Prader-Willi drug in doubt as FDA slaps full hold on program

Aardvark Therapeutics' lead asset, ARD-101, for Prader-Willi syndrome, has been placed on a full clinical hold by the FDA due to cardiac concerns. This action...

Supreme Court preserves access to abortion pill by mailRegulatory Approvals

18 May 2026

Supreme Court preserves access to abortion pill by mail

The Supreme Court has preserved mail-order access to the abortion pill mifepristone, issuing an indefinite stay on a lower court's ruling that aimed to...

aTyr Pharma Announces First Quarter 2026 Results and Provides Corporate UpdateRegulatory Approvals

18 May 2026

aTyr Pharma Announces First Quarter 2026 Results and Provides Corporate Update

aTyr Pharma announced its Q1 2026 results and a corporate update, highlighting a clear path forward for efzofitimod in pulmonary sarcoidosis. Following a Type...

Plus Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update on REYOBIQ™ Clinical Program and CNSide® Commercial RolloutRegulatory Approvals

18 May 2026

Plus Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update on REYOBIQ™ Clinical Program and CNSide® Commercial Rollout

Plus Therapeutics announced its Q1 2026 financial results and provided business updates. Key highlights include completing an upsized public offering...

Interim CDER head Høeg is out days after Makary: reportRegulatory Approvals

18 May 2026

Interim CDER head Høeg is out days after Makary: report

Tracy Beth Høeg, the interim director of the FDA's Center for Drug Evaluation and Research (CDER), is reportedly exiting the agency, just days after FDA...

Monopar Therapeutics Reports First Quarter 2026 Financial Results and Provides Business UpdatesRegulatory Approvals

15 May 2026

Monopar Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates

Monopar Therapeutics announced its first quarter 2026 financial results and provided key business updates. The company is on track to submit a New Drug...

BeOne wins mantle cell lymphoma approval, opening new therapy classRegulatory Approvals

15 May 2026

BeOne wins mantle cell lymphoma approval, opening new therapy class

The FDA has granted accelerated approval to BeOne Medicines’ BCL2 inhibitor, sonrotoclax (brand name Beqalzi), for the treatment of relapsed or refractory...

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