⚡ Top Events Today
First PROTAC drug gains FDA approval, validating new therapeutic modality
The FDA has approved the first-ever drug based on proteolysis-targeting chimera (PROTAC) technology.
Partner Therapeutics' Bizengri approved for rare NRG1+ cholangiocarcinoma
The FDA approved Bizengri for adults with advanced, unresectable or metastatic cholangiocarcinoma with an NRG1 gene fusion who have progressed on prior systemic therapy.
Gossamer Bio stock collapses 80% after Phase 3 PROSERA trial failure
The company announced the failure of its Phase 3 PROSERA trial, leading to an 80% stock drop and a subsequent securities class action lawsuit.
Alkermes' Lumryz meets all endpoints in Phase 3 for rare sleep disorder
The drug met all primary and key secondary endpoints in a pivotal Phase 3 study.
Ascendis Pharma halts IL-2 candidate development, retreating from oncology expansion
The company has ended internal development of its IL-2 candidate, which was once considered for accelerated approval.
📁 All Events (14335 stories)
Alkermes announced that its sodium oxybate drug, Lumryz, met all primary and key secondary endpoints in a Phase 3 study for a rare sleep disorder. This clinical success follows Alkermes' $2.37 billion acquisition of Avadel.
Alkermes announced that its sodium oxybate drug, Lumryz, met all primary and key secondary endpoints in a Phase 3 study for a rare sleep disorder. This clinical success follows Alkermes' $2.37 billion acquisition of Avadel.
This article describes a compilation of New Molecular Entity (NME) drug and new biologic approvals by the Center for Drug Evaluation and Research (CDER). The dataset covers approvals from 1985 to 2019, including both small molecule drugs and new biological products.
This article describes a compilation of New Molecular Entity (NME) drug and new biologic approvals by the Center for Drug Evaluation and Research (CDER). The dataset covers approvals from 1985 to 2019, including both small molecule drugs and new biological products.
Partner Therapeutics has secured FDA approval for Bizengri. The drug is indicated for adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion who have progressed on or after prior systemic therapy.
Partner Therapeutics has secured FDA approval for Bizengri. The drug is indicated for adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion who have progressed on or after prior systemic therapy.
ProBio Inc. and Curocell have achieved a significant milestone with the BLA regulatory approval of Anbal-cel (CRC01), a next-generation anti-CD19 CAR-T therapy. This approval highlights Korean innovation and marks commercial readiness for the drug.
ProBio Inc. and Curocell have achieved a significant milestone with the BLA regulatory approval of Anbal-cel (CRC01), a next-generation anti-CD19 CAR-T therapy. This approval highlights Korean innovation and marks commercial readiness for the drug.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in its stock price. Consequently, a securities class action lawsuit has been filed against the company and an executive by Hagens Berman, representing investors who purchased securities between June 16, 2025, and February 20, 2026.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in its stock price. Consequently, a securities class action lawsuit has been filed against the company and an executive by Hagens Berman, representing investors who purchased securities between Jun
The first PROTAC drug has gained FDA approval. This milestone bolsters the ambitions for targeted protein degradation and induced proximity in drug development.
The first PROTAC drug has gained FDA approval. This milestone bolsters the ambitions for targeted protein degradation and induced proximity in drug development.
The FDA has granted approval for Bizengri (zenocutuzumab-zbco), a drug designed to treat NRG1 fusion-positive cholangiocarcinoma, an ultra-rare and aggressive cancer. This approval represents the seventh under the National Priority Voucher Pilot Program.
The FDA has granted approval for Bizengri (zenocutuzumab-zbco), a drug designed to treat NRG1 fusion-positive cholangiocarcinoma, an ultra-rare and aggressive cancer. This approval represents the seventh under the National Priority Voucher Pilot Program.
Ascendis Pharma has ended the internal development of its IL-2 candidate. This decision signifies a pivot away from oncology expansion. The company had previously considered this asset for accelerated approval.
Ascendis Pharma has ended the internal development of its IL-2 candidate. This decision signifies a pivot away from oncology expansion. The company had previously considered this asset for accelerated approval.
fda_approval: selinexor — None
Ipsen has discontinued two liver disease drug candidates that were acquired from Albireo in 2023. One of these assets has been entirely set aside following the $952 million acquisition of Albireo.
Ipsen has discontinued two liver disease drug candidates that were acquired from Albireo in 2023. One of these assets has been entirely set aside following the $952 million acquisition of Albireo.
The FDA granted regular approval to rucaparib (Rubraca) on December 17, 2025. This approval is for adults with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor-directed therapy.
The FDA granted regular approval to rucaparib (Rubraca) on December 17, 2025. This approval is for adults with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor-directed therapy.
The FDA granted accelerated approval to rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
The FDA granted accelerated approval to rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo) from Eli Lilly and Company. This approval is for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation.
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo) from Eli Lilly and Company. This approval is for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation.
The FDA's May docket includes at least five PDUFA dates for regulatory decisions. These decisions pertain to one new product submitted via the 505(b)(2) pathway and four label expansions for existing products.
The FDA's May docket includes at least five PDUFA dates for regulatory decisions. These decisions pertain to one new product submitted via the 505(b)(2) pathway and four label expansions for existing products.
Gallant has advanced its IV-delivered stem cell therapy for canine osteoarthritis, receiving eligibility for expanded FDA-CVM conditional approval. The company is targeting conditional approval in 2028, supported by promising pilot data.
Gallant has advanced its IV-delivered stem cell therapy for canine osteoarthritis, receiving eligibility for expanded FDA-CVM conditional approval. The company is targeting conditional approval in 2028, supported by promising pilot data.
Pfizer has abandoned the remaining clinical-stage CD47 blocker and a T-cell engager, which were acquired through its $2.3 billion acquisition of Trillium Therapeutics. This decision signifies the failure of Pfizer's investment, as all candidates from the Trillium acquisition have now been scrapped.
Pfizer has abandoned the remaining clinical-stage CD47 blocker and a T-cell engager, which were acquired through its $2.3 billion acquisition of Trillium Therapeutics. This decision signifies the failure of Pfizer's investment, as all candidates from the Trillium acquisition have now been scrapped.
Viridian Therapeutics' anti-IGF-1R antibody met its primary endpoint in a second Phase 3 trial. This result clears the path for the company to file for FDA approval next year, aiming to challenge Amgen in the blockbuster market.
Viridian Therapeutics' anti-IGF-1R antibody met its primary endpoint in a second Phase 3 trial. This result clears the path for the company to file for FDA approval next year, aiming to challenge Amgen in the blockbuster market.