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Published on Jun 19, 2025

FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions

Aquestive Therapeutics has announced that the US Food and Drug Administration (FDA) acceptance of the Company’s New Drug Application (NDA) for epinephrine (Anaphylm) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis.1 …

Source: Consultant Live - Pending
Published on Jun 17, 2025

Aldeyra submits third reproxalap New Drug Application for the treatment of dry eye disease

Aldeyra Therapeutics has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.1 Previously, Aldeyra had received 2 Complete Response …

Source: Optometry Times - Pending
Published on Jun 19, 2025

Jyong’s $20M US IPO to help refile NDA of urological botanic drug

Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10 …

Source: BioWorld - Pending
Published on Jun 18, 2025

FDA approves twice-yearly lenacapavir as PrEP for HIV in adolescents, adults

On June 18, 2025, the FDA approved Gilead Sciences' lenacapavir (Yeztugo), an injectable HIV-1 capsid inhibitor, indicated as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who weigh at least 35 kg …

Source: Contemporary Pediatrics - Neutral
Published on Jun 16, 2025

Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment ...

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful …

Distribution channels: Healthcare & Pharmaceuticals Industry, Media, Advertising & PR ...
Published on 01:46 GMT

AD109 Improves OSA in Phase 3 SynAIRgy Trial, With Patrick Strollo, MD

On May 19, 2025, Apnimed announced that the phase 3 SynAIRgy clinical trial evaluating AD109 for obstructive sleep apnea (OSA) met its primary endpoint: mean change in apnea-hypopnea index (AHI) at 26 weeks. These topline results, similar to those from a …

Source: HCPLive - Pending
Published on Jun 19, 2025

Harmony Biosciences obtains favorable settlement in litigation over generic Wakix

Harmony Biosciences Holdings announced a settlement agreement with Lupin, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application for a generic version of Wakix (pitolisant hydrochloride). As part of the agreement, …

Source: Drug Store News - Pending
Published on Jun 19, 2025

FDA Approves First Twice-Yearly Injectable PrEP for HIV Prevention

The US Food and Drug Administration has approved lenacapavir (Yeztugo), the first twice-yearly injectable HIV-1 prevention option. As a capsid inhibitor, it offers a significant advancement in PrEP by reducing the burden of daily or bimonthly dosing for …

Source: Medical Dialogues - Indeterminate
Published on Jun 19, 2025

Biological Safety Cabinets Market to Reach USD 448.4 Million by 2032, Driven by Rising Biosafety Standards and Research ...

PUNE, India, June 19, 2025 /PRNewswire/ -- According to a recent market analysis published by Credence Research Inc., the global Biological Safety Cabinets (BSCs) market was valued at USD 215.2 million in 2023 and is projected to grow at a strong …

Source: WFMZ - Pennsylvania - Neutral
Published on Jun 18, 2025

Aldeyra Resubmits NDA for Reproxalap in Dry Eye Disease Treatment

Aldeyra Therapeutics has officially resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, targeting both the signs and symptoms of dry eye disease (DED). New Data Aligned with FDA Guidance …

Source: Ophthalmology Breaking News - Neutral
Published on Jun 16, 2025

Centessa Pharmaceuticals Announces Clearance of Investigational New Drug Application (IND) for ORX142, a Novel Orexin ...

BOSTON and LONDON, June 16, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on Jun 18, 2025

BIO 2025: Makary Calls for “New FDA” with Faster Reviews; Defends Agency’s Spring Job Cuts

[L.-R.] John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), hosts a fireside chat with FDA Commissioner Martin A. Makary, MD, MPH, at the BIO International Convention held in Boston. [Biotechnology International …

Source: Genetic Engineering & Biotechnology News -New York - Pending
Published on Jun 18, 2025

FDA Commissioner envisions fewer delays, more clinical trial flexibility and AI use

US Food and Drug Administration (FDA) Commissioner Dr. Marty Makary addressed concerns about the recent cuts impacting the agency’s ability to function by emphasising that they did not affect scientific reviewers or inspectors, at an ongoing industry …

Source: Pharmaceutical Technology - Pending
Published on Jun 16, 2025

Arkbio's New Drug Application For ADHD Therapeutic Azstarys Accepted And Granted Priority Review By China NMPA

(MENAFN- PR Newswire) SHANGHAI, June 15, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application ( …

Source: MENAFN - Indeterminate
Published on Jun 18, 2025

Bayer seeks US FDA approval for contrast agent, gadoquatrane for contrast─enhanced MRI of the CNS and other body regions

Bayer announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and …

Source: Pharmabiz.com - Neutral
Published on Jun 18, 2025

FDA Color Additive Scrutiny Expands to Pharmaceuticals

FDA’s draft guidance outlines a flexible approach that, under certain circumstances, allows applicants and manufacturers to replace a color additive in an approved or marketed drug product with one that conforms to FDA’s color additive regulations without …

Source: JD Supra - California - Neutral
Published on Jun 18, 2025

BIO 2025: Commissioner Martin Makary, M.D., M.P.H., discusses vision for FDA

Food and Drug Administration (FDA) Commissioner Martin A. Makary, M.D., M.P.H., sat down with the Biotechnology Innovation Organization (BIO) President and CEO John F. Crowley to discuss his vision for the FDA. “It’s been exhilarating to meet so many of …

Source: Bio News - Washington D.C. - Pending
Published on Jun 18, 2025

FDA Accepts NDA for Anaphylm™, a Sublingual Epinephrine Film for Treatment of Severe Allergic Reactions

Aquestive Therapeutics announced that the US FDA has accepted its New Drug Application (NDA) for Anaphylm™, a sublingual film formulation of epinephrine for the treatment of type 1 allergic reactions, including anaphylaxis. The agency has assigned a …

Source: Patient Care - Pending
Published on Jun 17, 2025

NDA Resubmitted for Investigational Dry Eye Therapy, Reproxalap

Aldeyra has resubmitted a new drug application (NDA) to the FDA for reproxalap, an investigational topical ocular therapy for the treatment of dry eye disease and allergic conjunctivitis, according to an Aldeyra news release published today. The …

Source: Managed Healthcare Executive - Neutral

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Published on June 19, 2025 - 21:41 GMT

10.0% CAGR Fuels Top 10 Cancer Drugs Market to $198.8 Billion by 2032

The top 10 cancer drugs market size is estimated to reach $198.8 billion by 2032, exhibiting a CAGR of 10.0% from 2023 to 2032. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Allied Market Research published a report, titled, …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 21:42 GMT

Antifibrinolytic Drugs Market: Major Growth & Business Opportunities with Akorn, Bayer, Mylan, Pfizer

Antifibrinolytic drugs are used to prevent fibrinolysis or lysis of blood clots or thrombus. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- The Antifibrinolytic Drugs Market size was estimated at $13.59 billion in 2018 and is …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...

Published on June 19, 2025 - 20:18 GMT

Immune Cell Therapy Market Set to Witness Significant Growth by 2025-2032 | Novartis, Autolus, Bluebird Bio, Cellectis

BURLINGAME, CA, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- The latest research study released by Coherent Market Insights on "Immune Cell Therapy Market 2025 Forecast to 2032" research provides accurate economic, global, and …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 20, 2025 - 05:36 GMT

Diasome Pharmaceuticals Completes Enrollment in Phase 2b OPTI-2 Trial of HDV-Insulin Lispro for Type 1 Diabetes

Phase 2b OPTI-2 trial to assess liver-targeted insulin’s ability to reduce hypoglycemia and improve postprandial control using Dexcom G7 CGM data CLEVELAND, OH, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- Diasome Pharmaceuticals, Inc., a …

Distribution channels: Healthcare & Pharmaceuticals Industry ...

Published on June 19, 2025 - 13:38 GMT

Virtual Clinical Trials Market Expands as Pharma Embraces Digital Research $14.42B by 2033 | DataM Intelligence

Virtual Clinical Trials market grows to $14.42B by 2033, driven by digital health, patient-centric models & AI-powered decentralized research. AUSTIN, TX, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- The Virtual Clinical Trials Market …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 12:45 GMT

Sustainable Pharmaceutical Packaging Market | Eco-Friendly Solutions, Trends & Growth Forecast 2025 | DataM Intelligence

The Sustainable Pharmaceutical Packaging Market is expected to reach at a CAGR of 12.7% during the forecast period 2025-2033. AUSTIN, TX, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- The Sustainable Pharmaceutical Packaging Market was …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 11:58 GMT

Pharma Grade Calcium Sulphate Global Market Report 2025: Forecasts Strong Growth With Key Trends And Drivers

The Business Research Company’s Pharma Grade Calcium Sulphate Global Market Report 2025 - Market Size, Trends, And Global Forecast 2025-2034 LONDON, GREATER LONDON, UNITED KINGDOM, June 19, 2025 /⁨EINPresswire.com⁩/ -- The Business Research …

Distribution channels: Business & Economy, Chemical Industry ...
Published on June 19, 2025 - 12:25 GMT

Brenus Pharma and InSphero have developed 3D tumor spheroids mimicking in vivo human colorectal cancer conditions

PPromising results show the impact of Brenus Pharma and InSphero’s collaboration in advancing translational immunotherapy through scalable 3D tumor models. SCHLIEREN, ZURICH, SWITZERLAND, June 19, 2025 /⁨EINPresswire.com⁩/ -- Brenus Pharma, a …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...

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Published on June 20, 2025 - 06:31 GMT

Three California Dispensaries Help Redefine Cannabis Retail Across Los Angeles and San Francisco

The Cure Company, Sensi Retail, and San Pancho Cannabis Club Introduce New Models of Design, Access, and Community in a Shifting Market LOS ANGELES, CA, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- As California’s cannabis industry matures, a …

Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
Published on June 20, 2025 - 06:10 GMT

Qalitex Examines Impact of Supply Chain Variability on Stability Outcomes

Qalitex warns that global supply chain variability may compromise product stability; urges brands to reassess shelf-life data when sourcing or logistics change. IRVINE, CA, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- Qalitex Laboratories, …

Distribution channels: Beauty & Hair Care, Companies ...
Published on June 20, 2025 - 06:09 GMT

New Implant Technique Offers Minimally Invasive Full-Mouth Restoration Option for Patients with Moderate Bone Loss

NY, NY, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- A new approach to full-mouth dental restoration is gaining traction among implant specialists seeking to balance durability, function, and aesthetic outcomes with reduced patient recovery …

Distribution channels: Companies, Culture, Society & Lifestyle ...
Published on June 20, 2025 - 06:07 GMT

JOINT STATEMENT FROM NATIONAL BAR ASSOCIATION AND NATIONAL MEDICAL ASSOCIATION

A United Call to Preserve and Strengthen DEI Commitments in Education and Beyond WASHINGTON, DC, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- The National Bar Association (NBA) and the National Medical Association (NMA)—the nation’s oldest …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on June 20, 2025 - 06:06 GMT

AZCOMP Technologies Announces Nationwide Expansion of Revenue Cycle Management Services

AZCOMP’s full-service RCM offering is now available to independent medical practices in all 50 states. MESA, AZ, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- AZCOMP Technologies, a long-time leader in medical billing software and support, …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 20, 2025 - 05:39 GMT

MedBetterHealth Selects EVO Care Group & Faith Home Healthcare as Key Partner For Medicare GUIDE Dementia Model

MedBetterHealth and Evo Care Group partner to expand Medicare dementia services through the CMS GUIDE Model, celebrated in Miramar FL. DAVIE, FL, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- In a powerful step toward transforming dementia …

Distribution channels: Education, Healthcare & Pharmaceuticals Industry ...
Published on June 20, 2025 - 05:38 GMT

Marquis Who's Who Honors Pamela M. Cipriano, DNP, for Expertise in Health Care

Dr. Cipriano, a distinguished figure in the medical community, has dedicated over three decades to advancing health care practices and patient outcomes. THOMASTON, CT, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Pamela M. Cipriano, DNP, …

Distribution channels: Beauty & Hair Care, Business & Economy ...
Published on June 20, 2025 - 05:37 GMT

Transworld Business Advisors of Eastern North Carolina Ranks in Top 10 Globally

Eastern NC Team Earns Multiple Honors at 2024 Transworld Conference GREENVILLE, NC, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Transworld Business Advisors of Eastern NC is pleased to announce that the office has been recognized as one …

Distribution channels: Automotive Industry, Building & Construction Industry ...
Published on June 20, 2025 - 05:36 GMT

Diasome Pharmaceuticals Completes Enrollment in Phase 2b OPTI-2 Trial of HDV-Insulin Lispro for Type 1 Diabetes

Phase 2b OPTI-2 trial to assess liver-targeted insulin’s ability to reduce hypoglycemia and improve postprandial control using Dexcom G7 CGM data CLEVELAND, OH, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- Diasome Pharmaceuticals, Inc., a …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 20, 2025 - 04:48 GMT

Japan Gene Therapy Market Growth: $148.06M in 2024 to $904.94M by 2033 | CAGR 20.3%

Japan's Gene Therapy Market is set to grow from $148.06M in 2024 to $904.94M by 2033, driven by innovation and a strong CAGR of 20.3% during 2025–2033. AUSTIN, TX, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Japan Gene Therapy …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on June 20, 2025 - 04:30 GMT

Dr. Mohana Rao Patibandla Named “The Best Neurosurgeon to Watch in 2025” by Insights Success Magazine

Dr. Mohana Rao Patibandla Named “The Best Neurosurgeon to Watch in 2025” by Insights Success Magazine GUNTUR, ANDHRA PRADESH, INDIA, June 20, 2025 /⁨EINPresswire.com⁩/ -- Dr. Mohana Rao Patibandla Named “The Best Neurosurgeon to Watch in 2025” by …

Distribution channels: Amusement, Gaming & Casino, Conferences & Trade Fairs ...
Published on June 20, 2025 - 02:00 GMT

ImagineHealth Partners with Deep Longevity to Bring Biological Age Testing to Thai Providers

BANGKOK, BANGKOK, THAILAND, June 20, 2025 /⁨EINPresswire.com⁩/ -- ImagineHealth, Thailand’s leading Longevity Facilitator, is proud to announce its exclusive partnership with Deep Longevity, a global leader in AI-powered aging clocks and biological …

Distribution channels: Healthcare & Pharmaceuticals Industry, Sports, Fitness & Recreation ...
Published on June 19, 2025 - 21:43 GMT

LATAM Women's HSDD Treatment Market Sees Steady Growth to $170 Million (3.8% CAGR)

Hyposexual desire disorder (HSDD) in women is defined as deficiency or lack of sexual fantasies and desire of sexual activity. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Allied Market Research recently said "LATAM …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 21:42 GMT

Antifibrinolytic Drugs Market: Major Growth & Business Opportunities with Akorn, Bayer, Mylan, Pfizer

Antifibrinolytic drugs are used to prevent fibrinolysis or lysis of blood clots or thrombus. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- The Antifibrinolytic Drugs Market size was estimated at $13.59 billion in 2018 and is …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 21:41 GMT

10.0% CAGR Fuels Top 10 Cancer Drugs Market to $198.8 Billion by 2032

The top 10 cancer drugs market size is estimated to reach $198.8 billion by 2032, exhibiting a CAGR of 10.0% from 2023 to 2032. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Allied Market Research published a report, titled, …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 21:36 GMT

Global Cough Remedies Market to Expand Rapidly as Cold and Flu Cases Rise | Projected to Reach $9.91 Billion by 2030

The global Cough Remedies market size was valued at $7084.5 million in 2020, and is projected to reach $9911.2 million by 2030, registering a CAGR of 3.4%. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- According to the report …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 21:36 GMT

The Artificial Intelligence in Medicines Market Is Set to Reach $18,119 Million | CAGR of 49.6%

The global artificial intelligence in medicines market was valued at $719 million in 2022 and is estimated to reach $18,119 million at a CAGR of 49.6%. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- The global Artificial …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 21:35 GMT

Parkinson's disease Drug Market | Forecasted to Cross Valuation of $10.4 Billion by 2031

The global Parkinson's disease drugs market size is projected to reach $10.4 billion by 2031, growing at a CAGR of 6.2% from 2022 to 2031. PORTLAND, OR, UNITED STATES, June 20, 2025 /⁨EINPresswire.com⁩/ -- Parkinson's disease (PD) drug …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on June 19, 2025 - 20:30 GMT

Productive Dentist Academy Announces First Clinical Calibration™ Institute Mastermind

New Program Tackles Inconsistent Patient Care & Low Case Acceptance with Team-based Training, Now for $595/Month with Founders Promo ANACORTES, WA, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- A lack of alignment among doctors and …

Distribution channels: Business & Economy, Companies ...
Published on June 19, 2025 - 20:18 GMT

Immune Cell Therapy Market Set to Witness Significant Growth by 2025-2032 | Novartis, Autolus, Bluebird Bio, Cellectis

BURLINGAME, CA, UNITED STATES, June 19, 2025 /⁨EINPresswire.com⁩/ -- The latest research study released by Coherent Market Insights on "Immune Cell Therapy Market 2025 Forecast to 2032" research provides accurate economic, global, and …

Distribution channels: Healthcare & Pharmaceuticals Industry ...