Therapeutic area intelligence for Not specified with 69 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 38
Catalysts: 20
Companies: 20

Companies

AbbVie →

Alembic Pharmaceuticals →

AstraZeneca →

Bayer →

Bayer Healthcare Pharmaceuticals →

Dr. Reddy's Labs →

Eli Lilly →

Guangdong Hengrui Pharmaceutical Co., Ltd. →

HAISCO Pharmaceutical →

Hetero Labs →

Hetero Labs Limited →

MSN Laboratories →

pharmaceutical developers →

QILU PHARM CO LTD →

Sandoz →

Shanghai Aucyun Pharmaceuticals →

Sichuan Credit Pharmaceutical Co., Ltd. →

Teva →

TEVA PHARMACEUTICALS, INC →

Zydus Pharmaceuticals →

Assets

Regulatory Approval →

Recent signals(38)

ClinicalAugust 5, 2026

First-in-human study of EI-1071 shows safety and tolerability in healthy volunteers

The study evaluated the safety, tolerability, and pharmacokinetics of EI-1071 in healthy volunteers.

CompetitiveAugust 5, 2026

FDA Submission Overview for ANDA212336 by Dr. Reddy's Labs

Reddy's Labs has submitted ANDA212336 with a standard review priority.

ClinicalAugust 4, 2026

Phase 1 Study of SYT-510 to Assess Bioavailability and Safety in Healthy Participants

A Phase 1 study is underway to evaluate the bioavailability and safety of SYT-510 in healthy participants.

RegulatoryAugust 3, 2026

FDA Submission Update for ANDA220421 by Hetero Labs

The FDA has received an application (ANDA220421) from Hetero Labs for Vemagal, currently under standard review.

RegulatoryAugust 1, 2026

FDA Acceptance of NDA220381 from Fresenius Kabi USA

The FDA has accepted the New Drug Application (NDA) 220381 from Fresenius Kabi USA for review.

RegulatoryAugust 1, 2026

FDA Acceptance of NDA219990 for Viatris Specialty

The FDA has accepted the NDA219990 application from Viatris Specialty for review.

RegulatoryJuly 31, 2026

FDA Grants TA Status for ANDA213093 from QILU PHARM CO LTD

The FDA has granted TA (Tentative Approval) status for ANDA213093 submitted by QILU PHARM CO LTD.

RegulatoryJuly 29, 2026

FDA Submission Overview for ANDA217477 by Hainan Poly Pharm

Hainan Poly Pharm has submitted ANDA217477 with a standard review priority.

StrategyJuly 27, 2026

FDA Acceptance of ANDA211182 by Hetero Labs

The FDA has accepted the application ANDA211182 from Hetero Labs for review.

RegulatoryJuly 27, 2026

FDA Submission Overview for ANDA215575 by QILU PHARM HAINAN

QILU PHARM HAINAN has submitted ANDA215575 with a standard review priority.

RegulatoryJuly 22, 2026

FDA Submission Update for ANDA220866 by Hetero Labs Limited

Hetero Labs Limited has submitted ANDA220866 with a standard review priority.

RegulatoryJuly 21, 2026

FDA Accepts NDA220482 from HAISCO Pharmaceutical for Review

The FDA has accepted the New Drug Application NDA220482 from HAISCO Pharmaceutical for review under standard priority.

CompetitiveJuly 21, 2026

FDA Submission Update for ANDA220724 by Zydus Pharmaceuticals

Zydus Pharmaceuticals has submitted ANDA220724 with a standard review priority.

RegulatoryJuly 20, 2026

Sandoz Inc. Submits ANDA220465 for FDA Review

Sandoz Inc. has submitted ANDA220465 to the FDA with a standard review priority.

StrategyJuly 20, 2026

FDA Submission Update for ANDA220143 by Hetero Labs

Hetero Labs Limited has submitted ANDA220143 with a standard review priority.

RegulatoryJuly 19, 2026

FDA Submission Status Update for ANDA220055 by MSN Laboratories

MSN Laboratories has submitted ANDA220055 with a standard review priority.

ClinicalJuly 17, 2026

Eli Lilly's LY4178256 Tolerance Study in Healthy Participants Initiated

Eli Lilly is conducting a study to evaluate the tolerance and side effects of LY4178256 in healthy participants over approximately 7 months.

ClinicalJuly 16, 2026

Guangdong Hengrui Pharma Compares Delivery Methods for SHR-1703 in Healthy Participants

A clinical study is underway to compare the bioavailability and safety of SHR-1703 Injection using two different delivery methods.

CompetitiveJuly 16, 2026

FDA Submission Update for ANDA218552 by APOTEX

APOTEX has submitted ANDA218552 with a standard review priority.

RegulatoryJuly 16, 2026

Alembic Pharmaceuticals submits ANDA220499 for FDA review

Alembic Pharmaceuticals has submitted ANDA220499 for FDA review with a standard review priority.

RegulatoryJuly 15, 2026

FDA Submission Status Update for ANDA220197 by Aizant Drug Research Solutions

The FDA has received ANDA220197 from Aizant Drug Research Solutions, currently under standard review.

RegulatoryJuly 15, 2026

FDA Submission Status Update for ANDA219207 by Shanghai Aucyun Pharmaceuticals

The FDA has received an application (ANDA219207) from Shanghai Aucyun Pharmaceuticals, currently under standard review.

RegulatoryJuly 15, 2026

Sandoz Inc. Submits ANDA220086 for FDA Review

Sandoz Inc. has submitted ANDA220086 to the FDA with a standard review priority.

ClinicalJuly 14, 2026

Phase I Study of HRS-8797 Initiated by Chengdu Suncadia Medicine

Chengdu Suncadia Medicine Co., Ltd. has initiated Phase I clinical trial to evaluate HRS-8797.

CompetitiveJuly 14, 2026

Sandoz Inc. Submits ANDA219346 for Review by FDA

Sandoz Inc. has submitted ANDA219346 for review, classified as a standard priority application.

ClinicalJuly 10, 2026

Phase 1 Study of BW-41012 by Shanghai Argo Biopharmaceutical Co.

Shanghai Argo Biopharmaceutical is conducting Phase 1 clinical trial for BW-41012 to assess its safety and pharmacokinetics.

ClinicalJuly 8, 2026

QuantX Biosciences initiates QX-4533 safety study in healthy participants

QuantX Biosciences is conducting a study to assess the safety and tolerability of QX-4533 in healthy participants.

ClinicalJuly 6, 2026

Teva initiates trial for TEV-56286 assessing pharmacokinetics and safety

Teva is conducting a trial to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 in healthy participants.

RegulatoryJuly 6, 2026

FDA Submission Update for ANDA217477 by Hainan Poly Pharm

Hainan Poly Pharm has submitted ANDA217477 with a standard review priority.

ClinicalJuly 6, 2026

Saninova Tablets Study Assesses Dose Proportionality and PK Linearity

A study is underway to evaluate the dose proportionality and pharmacokinetic linearity of Saninova Tablets in healthy participants.

CompetitiveJuly 4, 2026

FDA Submission Update for ANDA215575 by QILU PHARM HAINAN

QILU PHARM HAINAN has submitted ANDA215575 with a standard review priority.

ClinicalJuly 4, 2026

First-in-Human Study of SCB0020160 by SCBIO Inc. Underway

SCBIO Inc. is conducting a first-in-human trial for SCB0020160 to evaluate its safety and pharmacokinetics.

ClinicalJune 26, 2026

Phase 1 Study of ABBV-722 Shows Focus on Safety and Pharmacokinetics

AbbVie is conducting Phase 1 study to assess the safety, tolerability, and pharmacokinetics of ABBV-722 in healthy adults.

RegulatoryJune 23, 2026

Bayer Healthcare's NDA219627 Receives Approval from FDA

The FDA has approved NDA219627 submitted by Bayer Healthcare.

RegulatoryJune 18, 2026

Bayer's NDA219627 Receives Approval from FDA

Bayer Healthcare Pharmaceuticals has received approval for NDA219627 from the FDA.

StrategyJune 18, 2026

Alembic Pharmaceuticals Submits ANDA220639 for Review

Alembic Pharmaceuticals has submitted ANDA220639 for review with a standard review priority.

RegulatoryJune 18, 2026

TEVA Pharmaceuticals submits ANDA219413 for FDA review

TEVA Pharmaceuticals has submitted ANDA219413 to the FDA with a standard review priority.

StrategyJune 16, 2026

AstraZeneca Reports Strong Q1 2026 Revenue Growth and Positive NME Readouts

AstraZeneca reported a 13% increase in total revenue for Q1 2026, driven by strong product sales and positive readouts from new molecular entities (NMEs).

Upcoming catalysts

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Indications

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