⚡ Top Events Today
FDA Approves First-Ever PROTAC Drug, Validating New Therapeutic Modality
The FDA granted approval to the first drug utilizing Proteolysis Targeting Chimera (PROTAC) technology, a novel approach for targeted protein degradation.
Gossamer Bio Stock Plummets 80% After Phase 3 PROSERA Trial Failure
The company announced its Phase 3 PROSERA trial failed to meet its primary endpoint, resulting in an 80% stock price decline and a securities class action lawsuit.
Partner Therapeutics Gains FDA Approval for BIZENGRI in NRG1+ Cancers
BIZENGRI received FDA approval, becoming the first targeted therapy for patients with NRG1 fusion-positive cholangiocarcinoma.
Ascendis Pharma Halts IL-2 Program, Pivoting Away from Oncology Expansion
Ascendis Pharma has ceased internal development of its IL-2 candidate, an asset previously considered for accelerated approval.
ProBio and Curocell Secure BLA Approval for CAR-T Therapy Anbal-cel
The FDA approved the Biologics License Application (BLA) for Anbal-cel, a next-generation anti-CD19 CAR-T therapy.
📁 All Events (14302 stories)
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
Partner Therapeutics announced FDA approval of BIZENGRI (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma. This marks the first targeted therapy for NRG1+ cholangiocarcinoma. BIZENGRI is also approved for patients harboring NRG1 gene fusions in non-small cell lung cancer and pancreatic adenocarcinoma.
Partner Therapeutics announced FDA approval of BIZENGRI (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma. This marks the first targeted therapy for NRG1+ cholangiocarcinoma. BIZENGRI is also approved for patients harboring NRG1 gene fusions in non-small cell lung cancer and pancreati
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.
Lannett, its wholly owned subsidiary Lanexa Biologics, and Sunshine Lake Pharma have secured FDA approval for their drug Langlara.
Lannett, its wholly owned subsidiary Lanexa Biologics, and Sunshine Lake Pharma have secured FDA approval for their drug Langlara.
IDEAYA Biosciences announced that its Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint. The company plans to initiate the RTOR submission process with the first pre-submission in May, targeting completion of the NDA filing.
IDEAYA Biosciences announced that its Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint. The company plans to initiate the RTOR submission process with the first pre-submission in May, targeting completion of the NDA filing.